User login
Alcohol-related liver disease severity increased during COVID-19 pandemic
LAS VEGAS – Over the course of the COVID-19 pandemic, alcohol-related liver disease has increased in severity, a finding that is likely related to higher consumption of alcohol and reduced care. The difference was notable in higher Model for End-Stage Liver Disease–sodium (MELD-Na) scores, more signs of hepatic decompensation, and higher mortality rates.
“Alcohol consumption during the COVID-19 pandemic led to increased morbidity and mortality, specifically in patients that already had underlying liver disease. The importance of alcohol cessation, counseling, and close physician monitoring is emphasized, given continued or relapsed alcohol consumption can significantly affect quality of life, life expectancy, and liver transplantation candidacy,” research team member Lindsay A. Sobotka, DO, said in an interview. Dr. Sobotka is an assistant professor of gastroenterology, hepatology, and nutrition at the Ohio State University Wexner Medical Center, Columbus.
The research was presented by Ayushi Jain, MD, at the annual meeting of the American College of Gastroenterology. Dr. Jain is a resident at the Ohio State University Wexner Medical Center.
Dr. Jain noted that alcohol sales have gone up during the pandemic, with monthly sales up 14%-44% between February and September 2020, compared with the same months in previous years.
Decompensation rates rose
The researchers analyzed data from patients with alcoholic cirrhosis or alcoholic hepatitis who were seen at the Ohio State University Medical Center between March and August 2019, and between March and August 2020.
During the pandemic, the number of hospital admissions nearly doubled among alcoholic hepatitis patients (86 to 162), but declined slightly among patients with alcoholic cirrhosis (613 to 528), possibly because of efforts to manage decompensation and avoid hospitalizations during the pandemic, according to Dr. Jain. In total, 4 of 162 patients with alcoholic hepatitis and 14 of 528 patients with alcoholic cirrhosis had COVID-19 at the time of admission.
Higher mortality rates were seen during the pandemic, although this was only significant for alcoholic cirrhosis: 14.8% versus 7% for alcoholic hepatitis (P = .06) and 13.5% versus 7.4% for alcoholic cirrhosis (P = .001).
Among those with alcoholic hepatitis, there was no significant change in median Maddrey’s Discriminant Function during the pandemic (P = .51), but the researchers noted a significant decrease in steroid use, from 27 patients to 23 (P = .001). “This may be due to a statistically significant increase in GI bleeds and renal dysfunction that we noted during the pandemic,” said Dr. Jain.
Hepatic decompensation and critical care needs increased among patients admitted with alcoholic hepatitis, including hepatic encephalopathy (P = .037), gastrointestinal bleeding (P = .01), a need for increased oxygen (P = .024), vasopressor support (P = .005), and initiation of hemodialysis (P = .007). The median highest MELD-Na score during admission was also higher during the pandemic (24 vs. 23, P = .04).
Patients with alcoholic cirrhosis had greater decompensation as measured by ascites (P = .01), therapeutic paracentesis (P = .04), titration of diuretics (P = .005), acute kidney injury (P = .005), hepatorenal syndrome (P = .002), and spontaneous bacterial peritonitis (P = .04). They also had greater need for vasopressor support (9% to 14%; P = .006), were more likely to initiate hemodialysis (7% to 11%; P = .015), and had greater mortality (7% to 14%; P = .001).
In all, 212 patients reported increased alcohol intake, 161 reported little change over the past year, and 253 said they were abstinent. MELD-Na scores were highest in the increased group (27), compared with the unchanged group (24) and abstinent group (23) (P = .001).
More robust support needed
“This highlights that the increase in alcohol use seems to be associated with higher rates of more severe alcoholic hepatitis, and we are going to need to all be aware of and intervene in these individuals, and try to not only make health care more accessible, but help those with alcohol use disorder to reengage in some support systems [and] harm-reduction measures, to try to reduce the number of these episodes of admissions with severe alcoholic hepatitis,” said Paul Kwo, MD, who comoderated the session. Dr. Kwo is a professor of medicine at Stanford (Calif.) University.
Dr. Kwo suggested that the pandemic has presented dual challenges to patients with alcohol-related liver disease. One is that hospitals have filled up because of an influx of COVID-19 cases, which makes it hard for them to compete for limited resources. The other is that lockdowns and social interruptions may have interfered with the support systems that normally help them to keep sober and maintain health care. “The pandemic really disrupted everybody’s ecosystem substantially, and some of these individuals, as their ecosystems crumble, they don’t have other resources to engage in care, and then they present with far more advanced comorbidities than we might have seen prior to the pandemic,” said Dr. Kwo.
The findings underscore at least one lesson that can be drawn from the pandemic. “We now know that we have to develop more robust systems to provide support for all of these individuals,” said Dr. Kwo.
Comoderator Patricia D. Jones, MD, agreed, and expressed optimism. “We were forced develop more remote or virtual networks, so I think there are a lot of people that are taking advantage maybe of virtual [Alcoholics Anonymous], and that wasn’t something that they necessarily did [before the pandemic]. And so at least we’ve developed some parallel systems that hopefully people will benefit from,” said Dr. Jones, who is an assistant professor of medicine at the University of Miami.
She suggested that physicians should make inquiries about patients with alcohol-related liver disease and their social situations, and might consider trying to connect them to a social worker if called for. “I think that really speaking to the person about where they are would be beneficial,” said Dr. Jones.
Dr. Sobotka, Dr. Jain, Dr. Kwo, and Dr. Jones have no relevant financial disclosures.
LAS VEGAS – Over the course of the COVID-19 pandemic, alcohol-related liver disease has increased in severity, a finding that is likely related to higher consumption of alcohol and reduced care. The difference was notable in higher Model for End-Stage Liver Disease–sodium (MELD-Na) scores, more signs of hepatic decompensation, and higher mortality rates.
“Alcohol consumption during the COVID-19 pandemic led to increased morbidity and mortality, specifically in patients that already had underlying liver disease. The importance of alcohol cessation, counseling, and close physician monitoring is emphasized, given continued or relapsed alcohol consumption can significantly affect quality of life, life expectancy, and liver transplantation candidacy,” research team member Lindsay A. Sobotka, DO, said in an interview. Dr. Sobotka is an assistant professor of gastroenterology, hepatology, and nutrition at the Ohio State University Wexner Medical Center, Columbus.
The research was presented by Ayushi Jain, MD, at the annual meeting of the American College of Gastroenterology. Dr. Jain is a resident at the Ohio State University Wexner Medical Center.
Dr. Jain noted that alcohol sales have gone up during the pandemic, with monthly sales up 14%-44% between February and September 2020, compared with the same months in previous years.
Decompensation rates rose
The researchers analyzed data from patients with alcoholic cirrhosis or alcoholic hepatitis who were seen at the Ohio State University Medical Center between March and August 2019, and between March and August 2020.
During the pandemic, the number of hospital admissions nearly doubled among alcoholic hepatitis patients (86 to 162), but declined slightly among patients with alcoholic cirrhosis (613 to 528), possibly because of efforts to manage decompensation and avoid hospitalizations during the pandemic, according to Dr. Jain. In total, 4 of 162 patients with alcoholic hepatitis and 14 of 528 patients with alcoholic cirrhosis had COVID-19 at the time of admission.
Higher mortality rates were seen during the pandemic, although this was only significant for alcoholic cirrhosis: 14.8% versus 7% for alcoholic hepatitis (P = .06) and 13.5% versus 7.4% for alcoholic cirrhosis (P = .001).
Among those with alcoholic hepatitis, there was no significant change in median Maddrey’s Discriminant Function during the pandemic (P = .51), but the researchers noted a significant decrease in steroid use, from 27 patients to 23 (P = .001). “This may be due to a statistically significant increase in GI bleeds and renal dysfunction that we noted during the pandemic,” said Dr. Jain.
Hepatic decompensation and critical care needs increased among patients admitted with alcoholic hepatitis, including hepatic encephalopathy (P = .037), gastrointestinal bleeding (P = .01), a need for increased oxygen (P = .024), vasopressor support (P = .005), and initiation of hemodialysis (P = .007). The median highest MELD-Na score during admission was also higher during the pandemic (24 vs. 23, P = .04).
Patients with alcoholic cirrhosis had greater decompensation as measured by ascites (P = .01), therapeutic paracentesis (P = .04), titration of diuretics (P = .005), acute kidney injury (P = .005), hepatorenal syndrome (P = .002), and spontaneous bacterial peritonitis (P = .04). They also had greater need for vasopressor support (9% to 14%; P = .006), were more likely to initiate hemodialysis (7% to 11%; P = .015), and had greater mortality (7% to 14%; P = .001).
In all, 212 patients reported increased alcohol intake, 161 reported little change over the past year, and 253 said they were abstinent. MELD-Na scores were highest in the increased group (27), compared with the unchanged group (24) and abstinent group (23) (P = .001).
More robust support needed
“This highlights that the increase in alcohol use seems to be associated with higher rates of more severe alcoholic hepatitis, and we are going to need to all be aware of and intervene in these individuals, and try to not only make health care more accessible, but help those with alcohol use disorder to reengage in some support systems [and] harm-reduction measures, to try to reduce the number of these episodes of admissions with severe alcoholic hepatitis,” said Paul Kwo, MD, who comoderated the session. Dr. Kwo is a professor of medicine at Stanford (Calif.) University.
Dr. Kwo suggested that the pandemic has presented dual challenges to patients with alcohol-related liver disease. One is that hospitals have filled up because of an influx of COVID-19 cases, which makes it hard for them to compete for limited resources. The other is that lockdowns and social interruptions may have interfered with the support systems that normally help them to keep sober and maintain health care. “The pandemic really disrupted everybody’s ecosystem substantially, and some of these individuals, as their ecosystems crumble, they don’t have other resources to engage in care, and then they present with far more advanced comorbidities than we might have seen prior to the pandemic,” said Dr. Kwo.
The findings underscore at least one lesson that can be drawn from the pandemic. “We now know that we have to develop more robust systems to provide support for all of these individuals,” said Dr. Kwo.
Comoderator Patricia D. Jones, MD, agreed, and expressed optimism. “We were forced develop more remote or virtual networks, so I think there are a lot of people that are taking advantage maybe of virtual [Alcoholics Anonymous], and that wasn’t something that they necessarily did [before the pandemic]. And so at least we’ve developed some parallel systems that hopefully people will benefit from,” said Dr. Jones, who is an assistant professor of medicine at the University of Miami.
She suggested that physicians should make inquiries about patients with alcohol-related liver disease and their social situations, and might consider trying to connect them to a social worker if called for. “I think that really speaking to the person about where they are would be beneficial,” said Dr. Jones.
Dr. Sobotka, Dr. Jain, Dr. Kwo, and Dr. Jones have no relevant financial disclosures.
LAS VEGAS – Over the course of the COVID-19 pandemic, alcohol-related liver disease has increased in severity, a finding that is likely related to higher consumption of alcohol and reduced care. The difference was notable in higher Model for End-Stage Liver Disease–sodium (MELD-Na) scores, more signs of hepatic decompensation, and higher mortality rates.
“Alcohol consumption during the COVID-19 pandemic led to increased morbidity and mortality, specifically in patients that already had underlying liver disease. The importance of alcohol cessation, counseling, and close physician monitoring is emphasized, given continued or relapsed alcohol consumption can significantly affect quality of life, life expectancy, and liver transplantation candidacy,” research team member Lindsay A. Sobotka, DO, said in an interview. Dr. Sobotka is an assistant professor of gastroenterology, hepatology, and nutrition at the Ohio State University Wexner Medical Center, Columbus.
The research was presented by Ayushi Jain, MD, at the annual meeting of the American College of Gastroenterology. Dr. Jain is a resident at the Ohio State University Wexner Medical Center.
Dr. Jain noted that alcohol sales have gone up during the pandemic, with monthly sales up 14%-44% between February and September 2020, compared with the same months in previous years.
Decompensation rates rose
The researchers analyzed data from patients with alcoholic cirrhosis or alcoholic hepatitis who were seen at the Ohio State University Medical Center between March and August 2019, and between March and August 2020.
During the pandemic, the number of hospital admissions nearly doubled among alcoholic hepatitis patients (86 to 162), but declined slightly among patients with alcoholic cirrhosis (613 to 528), possibly because of efforts to manage decompensation and avoid hospitalizations during the pandemic, according to Dr. Jain. In total, 4 of 162 patients with alcoholic hepatitis and 14 of 528 patients with alcoholic cirrhosis had COVID-19 at the time of admission.
Higher mortality rates were seen during the pandemic, although this was only significant for alcoholic cirrhosis: 14.8% versus 7% for alcoholic hepatitis (P = .06) and 13.5% versus 7.4% for alcoholic cirrhosis (P = .001).
Among those with alcoholic hepatitis, there was no significant change in median Maddrey’s Discriminant Function during the pandemic (P = .51), but the researchers noted a significant decrease in steroid use, from 27 patients to 23 (P = .001). “This may be due to a statistically significant increase in GI bleeds and renal dysfunction that we noted during the pandemic,” said Dr. Jain.
Hepatic decompensation and critical care needs increased among patients admitted with alcoholic hepatitis, including hepatic encephalopathy (P = .037), gastrointestinal bleeding (P = .01), a need for increased oxygen (P = .024), vasopressor support (P = .005), and initiation of hemodialysis (P = .007). The median highest MELD-Na score during admission was also higher during the pandemic (24 vs. 23, P = .04).
Patients with alcoholic cirrhosis had greater decompensation as measured by ascites (P = .01), therapeutic paracentesis (P = .04), titration of diuretics (P = .005), acute kidney injury (P = .005), hepatorenal syndrome (P = .002), and spontaneous bacterial peritonitis (P = .04). They also had greater need for vasopressor support (9% to 14%; P = .006), were more likely to initiate hemodialysis (7% to 11%; P = .015), and had greater mortality (7% to 14%; P = .001).
In all, 212 patients reported increased alcohol intake, 161 reported little change over the past year, and 253 said they were abstinent. MELD-Na scores were highest in the increased group (27), compared with the unchanged group (24) and abstinent group (23) (P = .001).
More robust support needed
“This highlights that the increase in alcohol use seems to be associated with higher rates of more severe alcoholic hepatitis, and we are going to need to all be aware of and intervene in these individuals, and try to not only make health care more accessible, but help those with alcohol use disorder to reengage in some support systems [and] harm-reduction measures, to try to reduce the number of these episodes of admissions with severe alcoholic hepatitis,” said Paul Kwo, MD, who comoderated the session. Dr. Kwo is a professor of medicine at Stanford (Calif.) University.
Dr. Kwo suggested that the pandemic has presented dual challenges to patients with alcohol-related liver disease. One is that hospitals have filled up because of an influx of COVID-19 cases, which makes it hard for them to compete for limited resources. The other is that lockdowns and social interruptions may have interfered with the support systems that normally help them to keep sober and maintain health care. “The pandemic really disrupted everybody’s ecosystem substantially, and some of these individuals, as their ecosystems crumble, they don’t have other resources to engage in care, and then they present with far more advanced comorbidities than we might have seen prior to the pandemic,” said Dr. Kwo.
The findings underscore at least one lesson that can be drawn from the pandemic. “We now know that we have to develop more robust systems to provide support for all of these individuals,” said Dr. Kwo.
Comoderator Patricia D. Jones, MD, agreed, and expressed optimism. “We were forced develop more remote or virtual networks, so I think there are a lot of people that are taking advantage maybe of virtual [Alcoholics Anonymous], and that wasn’t something that they necessarily did [before the pandemic]. And so at least we’ve developed some parallel systems that hopefully people will benefit from,” said Dr. Jones, who is an assistant professor of medicine at the University of Miami.
She suggested that physicians should make inquiries about patients with alcohol-related liver disease and their social situations, and might consider trying to connect them to a social worker if called for. “I think that really speaking to the person about where they are would be beneficial,” said Dr. Jones.
Dr. Sobotka, Dr. Jain, Dr. Kwo, and Dr. Jones have no relevant financial disclosures.
AT ACG 2021
Step right up, folks, for a public dissection
The greatest autopsy on Earth?
The LOTME staff would like to apologize in advance. The following item contains historical facts.
P.T. Barnum is a rather controversial figure in American history. The greatest show on Earth was certainly popular in its day. However, Barnum got his start in 1835 by leasing a slave named Joyce Heth, an elderly Black woman who told vivid stories of caring for a young George Washington. He toured her around the country, advertising her as a 160-year-old woman who served as George Washington’s nanny. When Ms. Heth died the next year, Barnum sold tickets to the autopsy, charging the equivalent of $30 in today’s money.
When a doctor announced that Ms. Heth was actually 75-80 when she died, it caused great controversy in the press and ruined Barnum’s career. Wait, no, that’s not right. The opposite, actually. He weathered the storm, built his famous circus, and never again committed a hoax.
It’s difficult to quantify how wrong publicly dissecting a person and charging people to see said dissection is, but that was almost 200 years ago. At the very least, we can say that such terrible behavior is firmly in the distant past.
Oh wait.
David Saunders, a 98-year-old veteran of World War II and the Korean War, donated his body to science. His body, however, was purchased by DeathScience.org from a medical lab – with the buyer supposedly misleading the medical lab about its intentions, which was for use at the traveling Oddities and Curiosities Expo. Tickets went for up to $500 each to witness the public autopsy of Mr. Saunders’ body, which took place at a Marriott in Portland, Ore. It promised to be an exciting, all-day event from 9 a.m. to 4 p.m., with a break for lunch, of course. You can’t have an autopsy without a catered lunch.
Another public autopsy event was scheduled in Seattle but canceled after news of the first event broke. Oh, and for that extra little kick, Mr. Saunders died from COVID-19, meaning that all those paying customers were exposed.
P.T. Barnum is probably rolling over in his grave right now. His autopsy tickets were a bargain.
Go ahead, have that soda before math
We should all know by now that sugary drinks are bad, even artificially sweetened ones. It might not always stop us from drinking them, but we know the deal. But what if sugary drinks like soda could be helpful for girls in school?
You read that right. We said girls. A soda before class might have boys bouncing off the walls, but not girls. A recent study showed that not only was girls’ behavior unaffected by having a sugary drink, their math skills even improved.
Researchers analyzed the behavior of 4- to 6-year-old children before and after having a sugary drink. The sugar rush was actually calming for girls and helped them perform better with numerical skills, but the opposite was true for boys. “Our study is the first to provide large-scale experimental evidence on the impact of sugary drinks on preschool children. The results clearly indicate a causal impact of sugary drinks on children’s behavior and test scores,” Fritz Schiltz, PhD, said in a written statement.
This probably isn’t the green light to have as many sugary drinks as you want, but it might be interesting to see how your work is affected after a soda.
Chicken nuggets and the meat paradox
Two young children are fighting over the last chicken nugget when an adult comes in to see what’s going on.
Liam: Vegetable!
Olivia: Meat!
Liam: Chicken nuggets are vegetables!
Olivia: No, dorkface! They’re meat.
Caregiver: Good news, kids. You’re both right.
Olivia: How can we both be right?
At this point, a woman enters the room. She’s wearing a white lab coat, so she must be a scientist.
Dr. Scientist: You can’t both be right, Olivia. You are being fed a serving of the meat paradox. That’s why Liam here doesn’t know that chicken nuggets are made of chicken, which is a form of meat. Sadly, he’s not the only one.
In a recent study, scientists from Furman University in Greenville, S.C., found that 38% of 176 children aged 4-7 years thought that chicken nuggets were vegetables and more than 46% identified French fries as animal based.
Olivia: Did our caregiver lie to us, Dr. Scientist?
Dr. Scientist: Yes, Olivia. The researchers I mentioned explained that “many people experience unease while eating meat. Omnivores eat foods that entail animal suffering and death while at the same time endorsing the compassionate treatment of animals.” That’s the meat paradox.
Liam: What else did they say, Dr. Scientist?
Dr. Scientist: Over 70% of those children said that cows and pigs were not edible and 5% thought that cats and horses were. The investigators wrote “that children and youth should be viewed as agents of environmental change” in the future, but suggested that parents need to bring honesty to the table.
Caregiver: How did you get in here anyway? And how do you know their names?
Dr. Scientist: I’ve been rooting through your garbage for years. All in the name of science, of course.
Bedtimes aren’t just for children
There are multiple ways to prevent heart disease, but what if it could be as easy as switching your bedtime? A recent study in European Heart Journal–Digital Health suggests that there’s a sweet spot when it comes to sleep timing.
Through smartwatch-like devices, researchers measured the sleep-onset and wake-up times for 7 days in 88,026 participants aged 43-79 years. After 5.7 years of follow-up to see if anyone had a heart attack, stroke, or any other cardiovascular event, 3.6% developed some kind of cardiovascular disease.
Those who went to bed between 10 p.m. and 11 p.m. had a lower risk of developing heart disease. The risk was 25% higher for subjects who went to bed at midnight or later, 24% higher for bedtimes before 10 p.m., and 12% higher for bedtimes between 11 p.m. and midnight.
So, why can you go to bed before “The Tonight Show” and lower your cardiovascular risk but not before the nightly news? Well, it has something to do with your body’s natural clock.
“The optimum time to go to sleep is at a specific point in the body’s 24-hour cycle and deviations may be detrimental to health. The riskiest time was after midnight, potentially because it may reduce the likelihood of seeing morning light, which resets the body clock,” said study author Dr. David Plans of the University of Exeter, England.
Although a sleep schedule is preferred, it isn’t realistic all the time for those in certain occupations who might have to resort to other methods to keep their circadian clocks ticking optimally for their health. But if all it takes is prescribing a sleep time to reduce heart disease on a massive scale it would make a great “low-cost public health target.”
So bedtimes aren’t just for children.
The greatest autopsy on Earth?
The LOTME staff would like to apologize in advance. The following item contains historical facts.
P.T. Barnum is a rather controversial figure in American history. The greatest show on Earth was certainly popular in its day. However, Barnum got his start in 1835 by leasing a slave named Joyce Heth, an elderly Black woman who told vivid stories of caring for a young George Washington. He toured her around the country, advertising her as a 160-year-old woman who served as George Washington’s nanny. When Ms. Heth died the next year, Barnum sold tickets to the autopsy, charging the equivalent of $30 in today’s money.
When a doctor announced that Ms. Heth was actually 75-80 when she died, it caused great controversy in the press and ruined Barnum’s career. Wait, no, that’s not right. The opposite, actually. He weathered the storm, built his famous circus, and never again committed a hoax.
It’s difficult to quantify how wrong publicly dissecting a person and charging people to see said dissection is, but that was almost 200 years ago. At the very least, we can say that such terrible behavior is firmly in the distant past.
Oh wait.
David Saunders, a 98-year-old veteran of World War II and the Korean War, donated his body to science. His body, however, was purchased by DeathScience.org from a medical lab – with the buyer supposedly misleading the medical lab about its intentions, which was for use at the traveling Oddities and Curiosities Expo. Tickets went for up to $500 each to witness the public autopsy of Mr. Saunders’ body, which took place at a Marriott in Portland, Ore. It promised to be an exciting, all-day event from 9 a.m. to 4 p.m., with a break for lunch, of course. You can’t have an autopsy without a catered lunch.
Another public autopsy event was scheduled in Seattle but canceled after news of the first event broke. Oh, and for that extra little kick, Mr. Saunders died from COVID-19, meaning that all those paying customers were exposed.
P.T. Barnum is probably rolling over in his grave right now. His autopsy tickets were a bargain.
Go ahead, have that soda before math
We should all know by now that sugary drinks are bad, even artificially sweetened ones. It might not always stop us from drinking them, but we know the deal. But what if sugary drinks like soda could be helpful for girls in school?
You read that right. We said girls. A soda before class might have boys bouncing off the walls, but not girls. A recent study showed that not only was girls’ behavior unaffected by having a sugary drink, their math skills even improved.
Researchers analyzed the behavior of 4- to 6-year-old children before and after having a sugary drink. The sugar rush was actually calming for girls and helped them perform better with numerical skills, but the opposite was true for boys. “Our study is the first to provide large-scale experimental evidence on the impact of sugary drinks on preschool children. The results clearly indicate a causal impact of sugary drinks on children’s behavior and test scores,” Fritz Schiltz, PhD, said in a written statement.
This probably isn’t the green light to have as many sugary drinks as you want, but it might be interesting to see how your work is affected after a soda.
Chicken nuggets and the meat paradox
Two young children are fighting over the last chicken nugget when an adult comes in to see what’s going on.
Liam: Vegetable!
Olivia: Meat!
Liam: Chicken nuggets are vegetables!
Olivia: No, dorkface! They’re meat.
Caregiver: Good news, kids. You’re both right.
Olivia: How can we both be right?
At this point, a woman enters the room. She’s wearing a white lab coat, so she must be a scientist.
Dr. Scientist: You can’t both be right, Olivia. You are being fed a serving of the meat paradox. That’s why Liam here doesn’t know that chicken nuggets are made of chicken, which is a form of meat. Sadly, he’s not the only one.
In a recent study, scientists from Furman University in Greenville, S.C., found that 38% of 176 children aged 4-7 years thought that chicken nuggets were vegetables and more than 46% identified French fries as animal based.
Olivia: Did our caregiver lie to us, Dr. Scientist?
Dr. Scientist: Yes, Olivia. The researchers I mentioned explained that “many people experience unease while eating meat. Omnivores eat foods that entail animal suffering and death while at the same time endorsing the compassionate treatment of animals.” That’s the meat paradox.
Liam: What else did they say, Dr. Scientist?
Dr. Scientist: Over 70% of those children said that cows and pigs were not edible and 5% thought that cats and horses were. The investigators wrote “that children and youth should be viewed as agents of environmental change” in the future, but suggested that parents need to bring honesty to the table.
Caregiver: How did you get in here anyway? And how do you know their names?
Dr. Scientist: I’ve been rooting through your garbage for years. All in the name of science, of course.
Bedtimes aren’t just for children
There are multiple ways to prevent heart disease, but what if it could be as easy as switching your bedtime? A recent study in European Heart Journal–Digital Health suggests that there’s a sweet spot when it comes to sleep timing.
Through smartwatch-like devices, researchers measured the sleep-onset and wake-up times for 7 days in 88,026 participants aged 43-79 years. After 5.7 years of follow-up to see if anyone had a heart attack, stroke, or any other cardiovascular event, 3.6% developed some kind of cardiovascular disease.
Those who went to bed between 10 p.m. and 11 p.m. had a lower risk of developing heart disease. The risk was 25% higher for subjects who went to bed at midnight or later, 24% higher for bedtimes before 10 p.m., and 12% higher for bedtimes between 11 p.m. and midnight.
So, why can you go to bed before “The Tonight Show” and lower your cardiovascular risk but not before the nightly news? Well, it has something to do with your body’s natural clock.
“The optimum time to go to sleep is at a specific point in the body’s 24-hour cycle and deviations may be detrimental to health. The riskiest time was after midnight, potentially because it may reduce the likelihood of seeing morning light, which resets the body clock,” said study author Dr. David Plans of the University of Exeter, England.
Although a sleep schedule is preferred, it isn’t realistic all the time for those in certain occupations who might have to resort to other methods to keep their circadian clocks ticking optimally for their health. But if all it takes is prescribing a sleep time to reduce heart disease on a massive scale it would make a great “low-cost public health target.”
So bedtimes aren’t just for children.
The greatest autopsy on Earth?
The LOTME staff would like to apologize in advance. The following item contains historical facts.
P.T. Barnum is a rather controversial figure in American history. The greatest show on Earth was certainly popular in its day. However, Barnum got his start in 1835 by leasing a slave named Joyce Heth, an elderly Black woman who told vivid stories of caring for a young George Washington. He toured her around the country, advertising her as a 160-year-old woman who served as George Washington’s nanny. When Ms. Heth died the next year, Barnum sold tickets to the autopsy, charging the equivalent of $30 in today’s money.
When a doctor announced that Ms. Heth was actually 75-80 when she died, it caused great controversy in the press and ruined Barnum’s career. Wait, no, that’s not right. The opposite, actually. He weathered the storm, built his famous circus, and never again committed a hoax.
It’s difficult to quantify how wrong publicly dissecting a person and charging people to see said dissection is, but that was almost 200 years ago. At the very least, we can say that such terrible behavior is firmly in the distant past.
Oh wait.
David Saunders, a 98-year-old veteran of World War II and the Korean War, donated his body to science. His body, however, was purchased by DeathScience.org from a medical lab – with the buyer supposedly misleading the medical lab about its intentions, which was for use at the traveling Oddities and Curiosities Expo. Tickets went for up to $500 each to witness the public autopsy of Mr. Saunders’ body, which took place at a Marriott in Portland, Ore. It promised to be an exciting, all-day event from 9 a.m. to 4 p.m., with a break for lunch, of course. You can’t have an autopsy without a catered lunch.
Another public autopsy event was scheduled in Seattle but canceled after news of the first event broke. Oh, and for that extra little kick, Mr. Saunders died from COVID-19, meaning that all those paying customers were exposed.
P.T. Barnum is probably rolling over in his grave right now. His autopsy tickets were a bargain.
Go ahead, have that soda before math
We should all know by now that sugary drinks are bad, even artificially sweetened ones. It might not always stop us from drinking them, but we know the deal. But what if sugary drinks like soda could be helpful for girls in school?
You read that right. We said girls. A soda before class might have boys bouncing off the walls, but not girls. A recent study showed that not only was girls’ behavior unaffected by having a sugary drink, their math skills even improved.
Researchers analyzed the behavior of 4- to 6-year-old children before and after having a sugary drink. The sugar rush was actually calming for girls and helped them perform better with numerical skills, but the opposite was true for boys. “Our study is the first to provide large-scale experimental evidence on the impact of sugary drinks on preschool children. The results clearly indicate a causal impact of sugary drinks on children’s behavior and test scores,” Fritz Schiltz, PhD, said in a written statement.
This probably isn’t the green light to have as many sugary drinks as you want, but it might be interesting to see how your work is affected after a soda.
Chicken nuggets and the meat paradox
Two young children are fighting over the last chicken nugget when an adult comes in to see what’s going on.
Liam: Vegetable!
Olivia: Meat!
Liam: Chicken nuggets are vegetables!
Olivia: No, dorkface! They’re meat.
Caregiver: Good news, kids. You’re both right.
Olivia: How can we both be right?
At this point, a woman enters the room. She’s wearing a white lab coat, so she must be a scientist.
Dr. Scientist: You can’t both be right, Olivia. You are being fed a serving of the meat paradox. That’s why Liam here doesn’t know that chicken nuggets are made of chicken, which is a form of meat. Sadly, he’s not the only one.
In a recent study, scientists from Furman University in Greenville, S.C., found that 38% of 176 children aged 4-7 years thought that chicken nuggets were vegetables and more than 46% identified French fries as animal based.
Olivia: Did our caregiver lie to us, Dr. Scientist?
Dr. Scientist: Yes, Olivia. The researchers I mentioned explained that “many people experience unease while eating meat. Omnivores eat foods that entail animal suffering and death while at the same time endorsing the compassionate treatment of animals.” That’s the meat paradox.
Liam: What else did they say, Dr. Scientist?
Dr. Scientist: Over 70% of those children said that cows and pigs were not edible and 5% thought that cats and horses were. The investigators wrote “that children and youth should be viewed as agents of environmental change” in the future, but suggested that parents need to bring honesty to the table.
Caregiver: How did you get in here anyway? And how do you know their names?
Dr. Scientist: I’ve been rooting through your garbage for years. All in the name of science, of course.
Bedtimes aren’t just for children
There are multiple ways to prevent heart disease, but what if it could be as easy as switching your bedtime? A recent study in European Heart Journal–Digital Health suggests that there’s a sweet spot when it comes to sleep timing.
Through smartwatch-like devices, researchers measured the sleep-onset and wake-up times for 7 days in 88,026 participants aged 43-79 years. After 5.7 years of follow-up to see if anyone had a heart attack, stroke, or any other cardiovascular event, 3.6% developed some kind of cardiovascular disease.
Those who went to bed between 10 p.m. and 11 p.m. had a lower risk of developing heart disease. The risk was 25% higher for subjects who went to bed at midnight or later, 24% higher for bedtimes before 10 p.m., and 12% higher for bedtimes between 11 p.m. and midnight.
So, why can you go to bed before “The Tonight Show” and lower your cardiovascular risk but not before the nightly news? Well, it has something to do with your body’s natural clock.
“The optimum time to go to sleep is at a specific point in the body’s 24-hour cycle and deviations may be detrimental to health. The riskiest time was after midnight, potentially because it may reduce the likelihood of seeing morning light, which resets the body clock,” said study author Dr. David Plans of the University of Exeter, England.
Although a sleep schedule is preferred, it isn’t realistic all the time for those in certain occupations who might have to resort to other methods to keep their circadian clocks ticking optimally for their health. But if all it takes is prescribing a sleep time to reduce heart disease on a massive scale it would make a great “low-cost public health target.”
So bedtimes aren’t just for children.
Novel blood-based panel highly effective for early-stage HCC
A blood-based biomarker panel that includes DNA and protein markers featured a 71% sensitivity at 90% specificity for the detection of early-stage hepatocellular carcinoma (HCC) compared with the GALAD (gender, age, a-fetoprotein [AFP], Lens culinaris agglutinin-reactive AFP [AFP-L3], and des-gamma-carboxy-prothrombin [DCP]) score or AFP alone, according to research findings. The panel reportedly performed well in certain subgroups based on sex, presence of cirrhosis, and liver disease etiology.
The study, which included inpatients with HCC and controls without HCC but underlying liver disease, suggests the panel could be utilized in the detection of early stage disease in patients with well-established risk factors for HCC. Ultimately, this may lead to earlier treatment initiation and potentially improved clinical outcomes.
“A blood-based marker panel that detects early-stage HCC with higher sensitivity than current biomarker-based approaches could substantially benefit patients undergoing HCC surveillance,” wrote study authors Naga Chalasani, MD, of Indiana University, Indianapolis, and colleagues. Their report is in Clinical Gastroenterology and Hepatology.
HCC, which accounts for most primary liver cancers, generally occurs in patients with several established risk factors, including alcoholic liver disease or nonalcoholic fatty liver disease as well as chronic hepatitis B virus or hepatitis C virus infection. Current guidelines, such as those from the European Association for the Study of the Liver and those from the American Association for the Study of Liver Diseases, recommend surveillance of at-risk patients every 6 months by ultrasound with or without AFP measurement. When caught early, HCC is typically treatable and is associated with a higher rate of survival compared with late-stage disease. According to Dr. Chalasani and colleagues, however, the effectiveness of current recommended surveillance for very early stage or early stage HCC is poor, characterized by a 45% sensitivity for ultrasound and a 63% sensitivity for ultrasound coupled with AFP measurement.
The investigators of the multicenter, case-control study collected blood specimens from 135 patients with HCC as well as 302 age-matched controls with underlying liver disease but no HCC. Very early or early stage disease was seen in approximately 56.3% of patients with HCC, and intermediate, advanced, or terminal stage disease was seen in 43.7% of patients.
To predict cases of HCC, the researchers used a logistic regression algorithm to analyze 10 methylated DNA markers (MDMs) associated with HCC, methylated B3GALT6 (reference DNA marker), and 3 candidate proteins. Finally, the researchers compared the accuracy of the developed blood-based biomarker panel with other blood-based biomarkers – including the GALAD, AFP, AFP-L3, DCP – for the detection of HCC.
The multitarget HCC panel included 3 MDMs – HOXA1, EMX1, and TSPYL5. In addition, the panel included methylation reference marker B3GALT6 and the protein markers AFP and AFP-L3. The biomarker panel featured a higher sensitivity (71%; 95% confidence interval, 60-81) at 90% specificity for the detection of early stage HCC compared with the GALAD score (41%; 95% CI, 30-53) or AFP ≥ 7.32 ng/mL (45%; 95% CI, 33-57). The area under the curve for the novel HCC panel for the detection of any stage HCC was 0.92 vs. 0.87 for the GALAD and 0.81 for the AFP measurement alone. The researchers found that the performance of the test was similar between men and women in terms of sensitivity (79% and 84%, respectively). Moreover, the panel performed similarly well among subgroups based on presence of cirrhosis and liver disease etiology.
A potential limitation of this study was the inclusion of controls who were largely confirmed HCC negative by ultrasound, a technique that lacks sensitivity for detecting early stage HCC, the researchers noted. Given this limitation, the researchers suggest that some of the control participants may have had underlying HCC that was missed by ultrasound. Furthermore, the findings indicate that the cross-sectional nature of the study may also mean some of the control participants had HCCs that were undetectable at initial screening.
Despite the limitations of the study, the researchers reported that the novel, blood-based marker panel’s sensitivity for detecting early stage HCC likely supports its use “among at-risk patients to enhance HCC surveillance and improve early cancer detection.”
The study was funded by the Exact Sciences Corporation. The researchers reported conflicts of interest with several pharmaceutical companies.
Hepatocellular carcinoma (HCC) is frequently diagnosed at late stages, leading to a high mortality rate given the limited treatment options. One of the major barriers to early diagnosis of HCC is the suboptimal sensitivity of the current diagnostic modality. Most recently, liquid biopsy has been used to diagnose and prognosticate various tumors, including HCC.
In this study, Dr. Chalasani and colleagues developed a biomarker panel consisting of three methylated DNA markers, methylated B3GALT6 (reference DNA marker) and two proteins (AFP and AFP-L3), to diagnose HCC. This panel demonstrated higher sensitivity (71%) at 90% specificity for early-stage HCC than the GALAD score (41%) or AFP (45%). It is exciting news for clinicians since this novel blood-based test could identify patients who are qualified for curative HCC treatment without the limitations of image-based tests such as body habitus or renal function. Although the cohort is relatively small, the performance is equally good in subgroups of patients based on liver disease etiology, presence of cirrhosis, or sex. We are looking forward to seeing the validation data of this biomarker panel in larger independent cohorts and the studies that compare this panel to abdominal ultrasound, which is the most commonly used tool for HCC surveillance. Hopefully, the sensitivity of the biomarkers-based tests can be further increased, and the costs can be lowered in the near future with more studies in this field. A powerful and cost-effective biomarker-based test that can either replace or enhance current HCC surveillance tools will bring tremendous benefits to our patients.
Howard T. Lee, MD, is with the department of hepatology at Baylor College of Medicine, Houston. He has no conflicts.
Hepatocellular carcinoma (HCC) is frequently diagnosed at late stages, leading to a high mortality rate given the limited treatment options. One of the major barriers to early diagnosis of HCC is the suboptimal sensitivity of the current diagnostic modality. Most recently, liquid biopsy has been used to diagnose and prognosticate various tumors, including HCC.
In this study, Dr. Chalasani and colleagues developed a biomarker panel consisting of three methylated DNA markers, methylated B3GALT6 (reference DNA marker) and two proteins (AFP and AFP-L3), to diagnose HCC. This panel demonstrated higher sensitivity (71%) at 90% specificity for early-stage HCC than the GALAD score (41%) or AFP (45%). It is exciting news for clinicians since this novel blood-based test could identify patients who are qualified for curative HCC treatment without the limitations of image-based tests such as body habitus or renal function. Although the cohort is relatively small, the performance is equally good in subgroups of patients based on liver disease etiology, presence of cirrhosis, or sex. We are looking forward to seeing the validation data of this biomarker panel in larger independent cohorts and the studies that compare this panel to abdominal ultrasound, which is the most commonly used tool for HCC surveillance. Hopefully, the sensitivity of the biomarkers-based tests can be further increased, and the costs can be lowered in the near future with more studies in this field. A powerful and cost-effective biomarker-based test that can either replace or enhance current HCC surveillance tools will bring tremendous benefits to our patients.
Howard T. Lee, MD, is with the department of hepatology at Baylor College of Medicine, Houston. He has no conflicts.
Hepatocellular carcinoma (HCC) is frequently diagnosed at late stages, leading to a high mortality rate given the limited treatment options. One of the major barriers to early diagnosis of HCC is the suboptimal sensitivity of the current diagnostic modality. Most recently, liquid biopsy has been used to diagnose and prognosticate various tumors, including HCC.
In this study, Dr. Chalasani and colleagues developed a biomarker panel consisting of three methylated DNA markers, methylated B3GALT6 (reference DNA marker) and two proteins (AFP and AFP-L3), to diagnose HCC. This panel demonstrated higher sensitivity (71%) at 90% specificity for early-stage HCC than the GALAD score (41%) or AFP (45%). It is exciting news for clinicians since this novel blood-based test could identify patients who are qualified for curative HCC treatment without the limitations of image-based tests such as body habitus or renal function. Although the cohort is relatively small, the performance is equally good in subgroups of patients based on liver disease etiology, presence of cirrhosis, or sex. We are looking forward to seeing the validation data of this biomarker panel in larger independent cohorts and the studies that compare this panel to abdominal ultrasound, which is the most commonly used tool for HCC surveillance. Hopefully, the sensitivity of the biomarkers-based tests can be further increased, and the costs can be lowered in the near future with more studies in this field. A powerful and cost-effective biomarker-based test that can either replace or enhance current HCC surveillance tools will bring tremendous benefits to our patients.
Howard T. Lee, MD, is with the department of hepatology at Baylor College of Medicine, Houston. He has no conflicts.
A blood-based biomarker panel that includes DNA and protein markers featured a 71% sensitivity at 90% specificity for the detection of early-stage hepatocellular carcinoma (HCC) compared with the GALAD (gender, age, a-fetoprotein [AFP], Lens culinaris agglutinin-reactive AFP [AFP-L3], and des-gamma-carboxy-prothrombin [DCP]) score or AFP alone, according to research findings. The panel reportedly performed well in certain subgroups based on sex, presence of cirrhosis, and liver disease etiology.
The study, which included inpatients with HCC and controls without HCC but underlying liver disease, suggests the panel could be utilized in the detection of early stage disease in patients with well-established risk factors for HCC. Ultimately, this may lead to earlier treatment initiation and potentially improved clinical outcomes.
“A blood-based marker panel that detects early-stage HCC with higher sensitivity than current biomarker-based approaches could substantially benefit patients undergoing HCC surveillance,” wrote study authors Naga Chalasani, MD, of Indiana University, Indianapolis, and colleagues. Their report is in Clinical Gastroenterology and Hepatology.
HCC, which accounts for most primary liver cancers, generally occurs in patients with several established risk factors, including alcoholic liver disease or nonalcoholic fatty liver disease as well as chronic hepatitis B virus or hepatitis C virus infection. Current guidelines, such as those from the European Association for the Study of the Liver and those from the American Association for the Study of Liver Diseases, recommend surveillance of at-risk patients every 6 months by ultrasound with or without AFP measurement. When caught early, HCC is typically treatable and is associated with a higher rate of survival compared with late-stage disease. According to Dr. Chalasani and colleagues, however, the effectiveness of current recommended surveillance for very early stage or early stage HCC is poor, characterized by a 45% sensitivity for ultrasound and a 63% sensitivity for ultrasound coupled with AFP measurement.
The investigators of the multicenter, case-control study collected blood specimens from 135 patients with HCC as well as 302 age-matched controls with underlying liver disease but no HCC. Very early or early stage disease was seen in approximately 56.3% of patients with HCC, and intermediate, advanced, or terminal stage disease was seen in 43.7% of patients.
To predict cases of HCC, the researchers used a logistic regression algorithm to analyze 10 methylated DNA markers (MDMs) associated with HCC, methylated B3GALT6 (reference DNA marker), and 3 candidate proteins. Finally, the researchers compared the accuracy of the developed blood-based biomarker panel with other blood-based biomarkers – including the GALAD, AFP, AFP-L3, DCP – for the detection of HCC.
The multitarget HCC panel included 3 MDMs – HOXA1, EMX1, and TSPYL5. In addition, the panel included methylation reference marker B3GALT6 and the protein markers AFP and AFP-L3. The biomarker panel featured a higher sensitivity (71%; 95% confidence interval, 60-81) at 90% specificity for the detection of early stage HCC compared with the GALAD score (41%; 95% CI, 30-53) or AFP ≥ 7.32 ng/mL (45%; 95% CI, 33-57). The area under the curve for the novel HCC panel for the detection of any stage HCC was 0.92 vs. 0.87 for the GALAD and 0.81 for the AFP measurement alone. The researchers found that the performance of the test was similar between men and women in terms of sensitivity (79% and 84%, respectively). Moreover, the panel performed similarly well among subgroups based on presence of cirrhosis and liver disease etiology.
A potential limitation of this study was the inclusion of controls who were largely confirmed HCC negative by ultrasound, a technique that lacks sensitivity for detecting early stage HCC, the researchers noted. Given this limitation, the researchers suggest that some of the control participants may have had underlying HCC that was missed by ultrasound. Furthermore, the findings indicate that the cross-sectional nature of the study may also mean some of the control participants had HCCs that were undetectable at initial screening.
Despite the limitations of the study, the researchers reported that the novel, blood-based marker panel’s sensitivity for detecting early stage HCC likely supports its use “among at-risk patients to enhance HCC surveillance and improve early cancer detection.”
The study was funded by the Exact Sciences Corporation. The researchers reported conflicts of interest with several pharmaceutical companies.
A blood-based biomarker panel that includes DNA and protein markers featured a 71% sensitivity at 90% specificity for the detection of early-stage hepatocellular carcinoma (HCC) compared with the GALAD (gender, age, a-fetoprotein [AFP], Lens culinaris agglutinin-reactive AFP [AFP-L3], and des-gamma-carboxy-prothrombin [DCP]) score or AFP alone, according to research findings. The panel reportedly performed well in certain subgroups based on sex, presence of cirrhosis, and liver disease etiology.
The study, which included inpatients with HCC and controls without HCC but underlying liver disease, suggests the panel could be utilized in the detection of early stage disease in patients with well-established risk factors for HCC. Ultimately, this may lead to earlier treatment initiation and potentially improved clinical outcomes.
“A blood-based marker panel that detects early-stage HCC with higher sensitivity than current biomarker-based approaches could substantially benefit patients undergoing HCC surveillance,” wrote study authors Naga Chalasani, MD, of Indiana University, Indianapolis, and colleagues. Their report is in Clinical Gastroenterology and Hepatology.
HCC, which accounts for most primary liver cancers, generally occurs in patients with several established risk factors, including alcoholic liver disease or nonalcoholic fatty liver disease as well as chronic hepatitis B virus or hepatitis C virus infection. Current guidelines, such as those from the European Association for the Study of the Liver and those from the American Association for the Study of Liver Diseases, recommend surveillance of at-risk patients every 6 months by ultrasound with or without AFP measurement. When caught early, HCC is typically treatable and is associated with a higher rate of survival compared with late-stage disease. According to Dr. Chalasani and colleagues, however, the effectiveness of current recommended surveillance for very early stage or early stage HCC is poor, characterized by a 45% sensitivity for ultrasound and a 63% sensitivity for ultrasound coupled with AFP measurement.
The investigators of the multicenter, case-control study collected blood specimens from 135 patients with HCC as well as 302 age-matched controls with underlying liver disease but no HCC. Very early or early stage disease was seen in approximately 56.3% of patients with HCC, and intermediate, advanced, or terminal stage disease was seen in 43.7% of patients.
To predict cases of HCC, the researchers used a logistic regression algorithm to analyze 10 methylated DNA markers (MDMs) associated with HCC, methylated B3GALT6 (reference DNA marker), and 3 candidate proteins. Finally, the researchers compared the accuracy of the developed blood-based biomarker panel with other blood-based biomarkers – including the GALAD, AFP, AFP-L3, DCP – for the detection of HCC.
The multitarget HCC panel included 3 MDMs – HOXA1, EMX1, and TSPYL5. In addition, the panel included methylation reference marker B3GALT6 and the protein markers AFP and AFP-L3. The biomarker panel featured a higher sensitivity (71%; 95% confidence interval, 60-81) at 90% specificity for the detection of early stage HCC compared with the GALAD score (41%; 95% CI, 30-53) or AFP ≥ 7.32 ng/mL (45%; 95% CI, 33-57). The area under the curve for the novel HCC panel for the detection of any stage HCC was 0.92 vs. 0.87 for the GALAD and 0.81 for the AFP measurement alone. The researchers found that the performance of the test was similar between men and women in terms of sensitivity (79% and 84%, respectively). Moreover, the panel performed similarly well among subgroups based on presence of cirrhosis and liver disease etiology.
A potential limitation of this study was the inclusion of controls who were largely confirmed HCC negative by ultrasound, a technique that lacks sensitivity for detecting early stage HCC, the researchers noted. Given this limitation, the researchers suggest that some of the control participants may have had underlying HCC that was missed by ultrasound. Furthermore, the findings indicate that the cross-sectional nature of the study may also mean some of the control participants had HCCs that were undetectable at initial screening.
Despite the limitations of the study, the researchers reported that the novel, blood-based marker panel’s sensitivity for detecting early stage HCC likely supports its use “among at-risk patients to enhance HCC surveillance and improve early cancer detection.”
The study was funded by the Exact Sciences Corporation. The researchers reported conflicts of interest with several pharmaceutical companies.
mRNA COVID vaccine response found mostly robust in RA, SLE patients
Immunosuppressed patients with autoimmune diseases who received the Moderna mRNA-1273 SARS-CoV-2 two-dose vaccine series had a frequency of adverse events similar to the general population albeit with a somewhat reduced, but still significant, antibody response with no severe vaccine-related disease flares, results of a prospective, nonrandomized open-label comparative trial in Canada demonstrated.
At the same time, patients with RA who were taking rituximab and patients with systemic lupus erythematosus (SLE) who were taking mycophenolate mofetil seemed to have reduced humoral responses after receiving the vaccine, said Ines Colmegna, MD, reporting results of the COVID-19 Vaccine in Immunosuppressed Adults with Autoimmune Disease (COVIAAD) study as a late-breaking poster abstract at the virtual annual meeting of the American College of Rheumatology. Dr. Colmegna is an associate professor of rheumatology in the division of experimental medicine at McGill University, Montreal.
“The frequency of adverse events, specifically the reactogenicity in people with comorbid conditions regardless of their diagnosis, was similar to healthy controls in this study, and their frequency was similar also the initial studies in the general population,” Dr. Colmegna said.
COVIAAD prospectively enrolled 220 fully vaccinated patients, 162 with rheumatic disease (131 with RA, 23 with SLE, and 8 with other diseases) and 58 controls. Adverse events a week and a month after each dose was the primary outcome. The postvaccine presence of the IgG antibody against the SARS-CoV-2 spike protein and the receptor binding domain (IgG-RBD) was the secondary outcome. Dr. Colmegna said that the study will continue evaluating participants after they get a third dose.
The Canadian trial appears to validate the ACR’s COVID-19 vaccine guidance, the fourth version of which was issued in October, said Jeffrey Curtis, MD, MS, MPH, professor of immunology and rheumatology at the University of Alabama at Birmingham and lead of the ACR COVID-19 Vaccine Guidance Task Force. Specifically, the guidance recommends that patients on rituximab or other anti-CD20 B-cell–depleting agents discuss vaccine timing with their rheumatologist.
“A few things changed over time when there was a paucity of evidence for any vaccine, but as time has gone on, mostly we were more correct than we weren’t,” Dr. Curtis said of the task force’s work. “The evidence that now is in this poster with regard to systemic lupus erythematosus and mycophenolate mofetil is [that] you have impaired vaccine response. If you’re on a B-cell drug like rituximab, you really have impaired vaccine response.”
In the study, 100% of controls had immunogenicity in terms of anti-spike and anti-RBD levels after the first and second dose. The rate of immunogenicity after the first and second dose were 67% and 88% in all patients with RA, and 35% and 78% in patients with SLE who were taking mycophenolate mofetil. The subset of patients with RA on rituximab (n = 17) had rates of immunogenicity of 5.9% and 17.6%, respectively.
“Measured antibody response is not the only way in which people develop a response to a vaccine, and there are also similar responses that occur even in people who are on rituximab and have not developed antibodies,” Dr. Colmegna said. “That’s a very important message also that we need to convey to patients: The immune response really extends beyond antibody protection.”
Overall, disease activity in both patients with RA and SLE did not appreciably change from baseline within 7 days and 28 days of each vaccine dose.
The study raises important questions about the timing of the vaccine, particularly in patients on rituximab, Dr. Colmegna said in an interview. “In theory, there is no element to suggest that, if you would schedule the vaccine a month prior to the next dose of rituximab, the effect of the drug would have decreased the number of B cells, and that the possibility of developing antibodies in response to the vaccine might be better if you give rituximab a month later when the amount of the drug and the effect of the drug is maximal,” she said. The average interval between patients receiving rituximab and vaccines was 4.5 months, Dr. Colmegna said in answering a question after her presentation.
Dr. Curtis said that the effect of holding rituximab or the vaccine to boost antibodies “is somewhat yet unknown. We think it will help, but that’s not a guarantee,” he said. “We don’t have direct evidence that just because the drug impairs vaccine response, that holding that drug for a week or 2 is going to take care of the problem.”
The study does arm rheumatologists with more information for discussing COVID vaccines with vaccine-hesitant patients with autoimmune diseases, Dr. Curtis said.
“It gives them evidence that for most of our immunomodulatory drugs the vaccine works pretty well,” he said. “The poster provides evidence that, compared to healthy controls, the vaccine doesn’t work quite as well in some patients, but for most people it actually did work pretty well. That reinforces the message: Go get vaccinated because [you] will mount [an immune] response, even, if that response isn’t quite as brisk as it is in healthy people.”
Dr. Colmegna and Dr. Curtis have no relevant relationships to disclose. The study received funding from Health and Social Services Quebec.
Immunosuppressed patients with autoimmune diseases who received the Moderna mRNA-1273 SARS-CoV-2 two-dose vaccine series had a frequency of adverse events similar to the general population albeit with a somewhat reduced, but still significant, antibody response with no severe vaccine-related disease flares, results of a prospective, nonrandomized open-label comparative trial in Canada demonstrated.
At the same time, patients with RA who were taking rituximab and patients with systemic lupus erythematosus (SLE) who were taking mycophenolate mofetil seemed to have reduced humoral responses after receiving the vaccine, said Ines Colmegna, MD, reporting results of the COVID-19 Vaccine in Immunosuppressed Adults with Autoimmune Disease (COVIAAD) study as a late-breaking poster abstract at the virtual annual meeting of the American College of Rheumatology. Dr. Colmegna is an associate professor of rheumatology in the division of experimental medicine at McGill University, Montreal.
“The frequency of adverse events, specifically the reactogenicity in people with comorbid conditions regardless of their diagnosis, was similar to healthy controls in this study, and their frequency was similar also the initial studies in the general population,” Dr. Colmegna said.
COVIAAD prospectively enrolled 220 fully vaccinated patients, 162 with rheumatic disease (131 with RA, 23 with SLE, and 8 with other diseases) and 58 controls. Adverse events a week and a month after each dose was the primary outcome. The postvaccine presence of the IgG antibody against the SARS-CoV-2 spike protein and the receptor binding domain (IgG-RBD) was the secondary outcome. Dr. Colmegna said that the study will continue evaluating participants after they get a third dose.
The Canadian trial appears to validate the ACR’s COVID-19 vaccine guidance, the fourth version of which was issued in October, said Jeffrey Curtis, MD, MS, MPH, professor of immunology and rheumatology at the University of Alabama at Birmingham and lead of the ACR COVID-19 Vaccine Guidance Task Force. Specifically, the guidance recommends that patients on rituximab or other anti-CD20 B-cell–depleting agents discuss vaccine timing with their rheumatologist.
“A few things changed over time when there was a paucity of evidence for any vaccine, but as time has gone on, mostly we were more correct than we weren’t,” Dr. Curtis said of the task force’s work. “The evidence that now is in this poster with regard to systemic lupus erythematosus and mycophenolate mofetil is [that] you have impaired vaccine response. If you’re on a B-cell drug like rituximab, you really have impaired vaccine response.”
In the study, 100% of controls had immunogenicity in terms of anti-spike and anti-RBD levels after the first and second dose. The rate of immunogenicity after the first and second dose were 67% and 88% in all patients with RA, and 35% and 78% in patients with SLE who were taking mycophenolate mofetil. The subset of patients with RA on rituximab (n = 17) had rates of immunogenicity of 5.9% and 17.6%, respectively.
“Measured antibody response is not the only way in which people develop a response to a vaccine, and there are also similar responses that occur even in people who are on rituximab and have not developed antibodies,” Dr. Colmegna said. “That’s a very important message also that we need to convey to patients: The immune response really extends beyond antibody protection.”
Overall, disease activity in both patients with RA and SLE did not appreciably change from baseline within 7 days and 28 days of each vaccine dose.
The study raises important questions about the timing of the vaccine, particularly in patients on rituximab, Dr. Colmegna said in an interview. “In theory, there is no element to suggest that, if you would schedule the vaccine a month prior to the next dose of rituximab, the effect of the drug would have decreased the number of B cells, and that the possibility of developing antibodies in response to the vaccine might be better if you give rituximab a month later when the amount of the drug and the effect of the drug is maximal,” she said. The average interval between patients receiving rituximab and vaccines was 4.5 months, Dr. Colmegna said in answering a question after her presentation.
Dr. Curtis said that the effect of holding rituximab or the vaccine to boost antibodies “is somewhat yet unknown. We think it will help, but that’s not a guarantee,” he said. “We don’t have direct evidence that just because the drug impairs vaccine response, that holding that drug for a week or 2 is going to take care of the problem.”
The study does arm rheumatologists with more information for discussing COVID vaccines with vaccine-hesitant patients with autoimmune diseases, Dr. Curtis said.
“It gives them evidence that for most of our immunomodulatory drugs the vaccine works pretty well,” he said. “The poster provides evidence that, compared to healthy controls, the vaccine doesn’t work quite as well in some patients, but for most people it actually did work pretty well. That reinforces the message: Go get vaccinated because [you] will mount [an immune] response, even, if that response isn’t quite as brisk as it is in healthy people.”
Dr. Colmegna and Dr. Curtis have no relevant relationships to disclose. The study received funding from Health and Social Services Quebec.
Immunosuppressed patients with autoimmune diseases who received the Moderna mRNA-1273 SARS-CoV-2 two-dose vaccine series had a frequency of adverse events similar to the general population albeit with a somewhat reduced, but still significant, antibody response with no severe vaccine-related disease flares, results of a prospective, nonrandomized open-label comparative trial in Canada demonstrated.
At the same time, patients with RA who were taking rituximab and patients with systemic lupus erythematosus (SLE) who were taking mycophenolate mofetil seemed to have reduced humoral responses after receiving the vaccine, said Ines Colmegna, MD, reporting results of the COVID-19 Vaccine in Immunosuppressed Adults with Autoimmune Disease (COVIAAD) study as a late-breaking poster abstract at the virtual annual meeting of the American College of Rheumatology. Dr. Colmegna is an associate professor of rheumatology in the division of experimental medicine at McGill University, Montreal.
“The frequency of adverse events, specifically the reactogenicity in people with comorbid conditions regardless of their diagnosis, was similar to healthy controls in this study, and their frequency was similar also the initial studies in the general population,” Dr. Colmegna said.
COVIAAD prospectively enrolled 220 fully vaccinated patients, 162 with rheumatic disease (131 with RA, 23 with SLE, and 8 with other diseases) and 58 controls. Adverse events a week and a month after each dose was the primary outcome. The postvaccine presence of the IgG antibody against the SARS-CoV-2 spike protein and the receptor binding domain (IgG-RBD) was the secondary outcome. Dr. Colmegna said that the study will continue evaluating participants after they get a third dose.
The Canadian trial appears to validate the ACR’s COVID-19 vaccine guidance, the fourth version of which was issued in October, said Jeffrey Curtis, MD, MS, MPH, professor of immunology and rheumatology at the University of Alabama at Birmingham and lead of the ACR COVID-19 Vaccine Guidance Task Force. Specifically, the guidance recommends that patients on rituximab or other anti-CD20 B-cell–depleting agents discuss vaccine timing with their rheumatologist.
“A few things changed over time when there was a paucity of evidence for any vaccine, but as time has gone on, mostly we were more correct than we weren’t,” Dr. Curtis said of the task force’s work. “The evidence that now is in this poster with regard to systemic lupus erythematosus and mycophenolate mofetil is [that] you have impaired vaccine response. If you’re on a B-cell drug like rituximab, you really have impaired vaccine response.”
In the study, 100% of controls had immunogenicity in terms of anti-spike and anti-RBD levels after the first and second dose. The rate of immunogenicity after the first and second dose were 67% and 88% in all patients with RA, and 35% and 78% in patients with SLE who were taking mycophenolate mofetil. The subset of patients with RA on rituximab (n = 17) had rates of immunogenicity of 5.9% and 17.6%, respectively.
“Measured antibody response is not the only way in which people develop a response to a vaccine, and there are also similar responses that occur even in people who are on rituximab and have not developed antibodies,” Dr. Colmegna said. “That’s a very important message also that we need to convey to patients: The immune response really extends beyond antibody protection.”
Overall, disease activity in both patients with RA and SLE did not appreciably change from baseline within 7 days and 28 days of each vaccine dose.
The study raises important questions about the timing of the vaccine, particularly in patients on rituximab, Dr. Colmegna said in an interview. “In theory, there is no element to suggest that, if you would schedule the vaccine a month prior to the next dose of rituximab, the effect of the drug would have decreased the number of B cells, and that the possibility of developing antibodies in response to the vaccine might be better if you give rituximab a month later when the amount of the drug and the effect of the drug is maximal,” she said. The average interval between patients receiving rituximab and vaccines was 4.5 months, Dr. Colmegna said in answering a question after her presentation.
Dr. Curtis said that the effect of holding rituximab or the vaccine to boost antibodies “is somewhat yet unknown. We think it will help, but that’s not a guarantee,” he said. “We don’t have direct evidence that just because the drug impairs vaccine response, that holding that drug for a week or 2 is going to take care of the problem.”
The study does arm rheumatologists with more information for discussing COVID vaccines with vaccine-hesitant patients with autoimmune diseases, Dr. Curtis said.
“It gives them evidence that for most of our immunomodulatory drugs the vaccine works pretty well,” he said. “The poster provides evidence that, compared to healthy controls, the vaccine doesn’t work quite as well in some patients, but for most people it actually did work pretty well. That reinforces the message: Go get vaccinated because [you] will mount [an immune] response, even, if that response isn’t quite as brisk as it is in healthy people.”
Dr. Colmegna and Dr. Curtis have no relevant relationships to disclose. The study received funding from Health and Social Services Quebec.
FROM ACR 2021
AHA 2021 puts scientific dialogue, health equity center stage
Virtual platforms democratized scientific meetings during the COVID-19 pandemic but, as any meeting-goer will tell you, it’s the questions from the floor and the back-and-forth of an expert panel that often reveal the importance of and/or problems with a presentation. It’s the scrutiny that makes the science resonate, especially in this postfactual era.
The all-virtual American Heart Association Scientific Sessions 2021 is looking to recreate the engagement of an in-person meeting by offering more live interactive events. They range from seven late-breaking science (LBS) sessions to Saturday’s fireside chat on the Pfizer and Moderna COVID-19 vaccines and Monday’s dive into the controversial new AHA/American College of Cardiology Chest Pain guidelines.
To help digest the latest science, attendees will be able to have their questions answered in real-time via Slido, meet with the trialists, and hear live commentary from key opinion leaders after the live events. A networking function will also allow attendees and exhibitors to chat or meet virtually.
“In this day and age, many people pretty quickly can get access to the science but it’s what I call the IC sort of phenomenon – the presentation of the information, the context of the information, putting it into how I’m going to use it in my practice, and then the critical appraisal – that’s what most people want at the Scientific Sessions,” program committee chair Manesh R. Patel, MD, of Duke University School of Medicine, said in an interview. “We’re all craving ways in which we can interact with one another to put things in context.”
Plans for a hybrid in-person meeting in Boston were scuttled in September because of the Delta variant surge, but the theme of the meeting remained: “One World. Together for Science.” Attendees will be able to access more than 500 live and on-demand sessions including 117 oral abstracts, 286 poster sessions, 59 moderated digital posters, and over a dozen sessions focused on strategies to promote health equity.
“Last year there was a Presidential Session and a statement on structural racism, so we wanted to take the next step and say, What are the ways in which people are starting to interact and do things to make a difference?” explained Dr. Patel. “So, this year, you’ll see different versions of that from the Main Event session, which has some case vignettes and a panel discussion, to other health equity sessions that describe not just COVID care, but blood pressure care, maternal-fetal medicine, and congenital kids. Wherever we can, we’ve tried to infuse it throughout the sessions and will continue to.”
Late-breaking science
The LBS sessions kick off at 9:30 a.m. ET Saturday with AVATAR, a randomized trial of aortic valve replacement vs. watchful waiting in severe aortic stenosis proved asymptomatic through exercise testing.
“The findings of that trial, depending on what they are, could certainly impact clinical practice because it’s a very common scenario in which we have elderly patients with aortic valve stenosis that might be severe but they may not be symptomatic,” he said.
It’s followed by a randomized trial from the Cardiothoracic Surgical Trials Network, examining whether tricuspid repair at the time of mitral valve surgery leads to beneficial outcomes. “I think it’s a pretty important study,” Dr. Patel said, “because it’ll again affect how we think about our clinical practice.”
Rounding out the LBS.01 session is RAPID CABG, comparing early vs. delayed coronary bypass graft surgery (CABG) in patients with acute coronary syndromes on ticagrelor, and the pivotal U.S. VEST trial of an external support device already approved in Europe for saphenous vein grafts during CABG.
Saturday’s LBS.02 at 3:00 p.m. ET is devoted to hypertension and looks at how the COVID-19 pandemic affected blood pressure control. There’s also a study of remotely delivered hypertension and lipid management in 10,000 patients across the Partners Healthcare System and a cluster randomized trial of a village doctor–led blood pressure intervention in rural China.
Sunday’s LBS.03 at 8:00 a.m. ET is focused on atrial arrhythmias, starting with the CRAVE trial examining the effect of caffeine consumption on cardiac ectopy burden in 108 patients using an N-of-1 design and 2-day blocks on and off caffeine. “There’s an ability to identify a dose response that you get arrhythmias when you increase the amount of coffee you drink vs. not in an individual, so I think that will be likely discussed a lot and worth paying attention to,” Dr. Patel said.
The session also includes GIRAF, a comparison of cognitive outcomes with dabigatran (Pradaxa) vs. warfarin (Coumadin) in nonvalvular atrial fibrillation (AF); PALACS, a randomized trial examining whether left-sided pericardiotomy prevents AF after cardiac surgery; and AMAZE, which study sponsor AtriCure revealed missed its primary efficacy endpoint of freedom from AF with the LARIAT suture delivery device for left atrial appendage closure plus pulmonary vein isolation.
LBS.04 at 3:30 p.m. ET Sunday takes on digital health, with results from the nonrandomized Fitbit Heart Study on AF notifications from 450,000 participants wearing a single-lead ECG patch. “A lot of technologies claim that they can detect things, and we should ask that people go through the rigorous evaluation to see if they in fact do. So, in that respect, I think it›s an important step,” observed Dr. Patel.
Also on tap is I-STOP-AFib, another N-of-1 study using mobile apps and the AliveCor device to identify individual AF triggers; and REVeAL-HF, a 4,000-patient study examining whether electronic alerts that provide clinicians with prognostic information on their heart failure (HF) patients will reduce mortality and 30-day HF hospitalizations.
LBS.05 at 5:00 p.m. ET provides new information from EMPEROR-Preserved in HF with preserved ejection fraction and main results from EMPULSE, also using the sodium-glucose cotransporter 2 (SGLT2) inhibitor empagliflozin (Jardiance) in 530 patients hospitalized for acute HF.
The session also features CHIEF-HF, a randomized trial leveraging mobile technologies to test whether 12 weeks of another SGLT2 inhibitor, canagliflozin (Invokana), is superior to placebo for improving HF symptoms; and DREAM-HF, a comparison of transendocardial delivery of allogeneic mesenchymal precursor cells vs. a sham comparator in chronic HF as a result of left ventricular systolic dysfunction.
Monday’s LBS.06 at 8:00 a.m. ET details the safety and cholesterol-lowering efficacy of MK-0616, an investigational oral PCSK9 inhibitor. “It’s just a phase 2 [trial], but there’s interest in an oral PCSK9 inhibitor, given that the current ones are subcutaneous,” Dr. Patel said.
Results will also be presented from PREPARE-IT 2, which tested icosapent ethyl vs. placebo in outpatients with COVID-19. In the recently reported PREPARE-IT 1, a loading dose of icosapent ethyl failed to reduce the risk of hospitalization with SARS-CoV-2 infection among at-risk individuals.
LBS.07 at 11:00 a.m. Monday completes the late-breakers with new results from ASCEND, this time examining the effect of aspirin on dementia and cognitive impairment in patients with diabetes.
Next up is a look at the effectiveness of P2Y12 inhibitors in hospitalized patients with COVID-19 in the adaptive ACTIV-4a trial, followed by results of the pivotal phase 3 REVERSE-IT trial of bentracimab, a recombinant human monoclonal antibody antigen fragment designed to reverse the antiplatelet activity of ticagrelor in the event of major bleeding or when urgent surgery is needed.
Closing out the session is AXIOMATIC-TKR, a double-blind comparison of the safety and efficacy of the investigational oral factor XI anticoagulant JNJ-70033093 vs. subcutaneous enoxaparin (Lovenox) in elective total knee replacement.
For those searching for more AHA-related science online, the Resuscitation Science Symposium (ReSS) will run from this Friday through Sunday and the Quality of Care and Outcomes Research (QCOR) Scientific Sessions will take the stage next Monday, Nov. 15.
A version of this article first appeared on Medscape.com.
Virtual platforms democratized scientific meetings during the COVID-19 pandemic but, as any meeting-goer will tell you, it’s the questions from the floor and the back-and-forth of an expert panel that often reveal the importance of and/or problems with a presentation. It’s the scrutiny that makes the science resonate, especially in this postfactual era.
The all-virtual American Heart Association Scientific Sessions 2021 is looking to recreate the engagement of an in-person meeting by offering more live interactive events. They range from seven late-breaking science (LBS) sessions to Saturday’s fireside chat on the Pfizer and Moderna COVID-19 vaccines and Monday’s dive into the controversial new AHA/American College of Cardiology Chest Pain guidelines.
To help digest the latest science, attendees will be able to have their questions answered in real-time via Slido, meet with the trialists, and hear live commentary from key opinion leaders after the live events. A networking function will also allow attendees and exhibitors to chat or meet virtually.
“In this day and age, many people pretty quickly can get access to the science but it’s what I call the IC sort of phenomenon – the presentation of the information, the context of the information, putting it into how I’m going to use it in my practice, and then the critical appraisal – that’s what most people want at the Scientific Sessions,” program committee chair Manesh R. Patel, MD, of Duke University School of Medicine, said in an interview. “We’re all craving ways in which we can interact with one another to put things in context.”
Plans for a hybrid in-person meeting in Boston were scuttled in September because of the Delta variant surge, but the theme of the meeting remained: “One World. Together for Science.” Attendees will be able to access more than 500 live and on-demand sessions including 117 oral abstracts, 286 poster sessions, 59 moderated digital posters, and over a dozen sessions focused on strategies to promote health equity.
“Last year there was a Presidential Session and a statement on structural racism, so we wanted to take the next step and say, What are the ways in which people are starting to interact and do things to make a difference?” explained Dr. Patel. “So, this year, you’ll see different versions of that from the Main Event session, which has some case vignettes and a panel discussion, to other health equity sessions that describe not just COVID care, but blood pressure care, maternal-fetal medicine, and congenital kids. Wherever we can, we’ve tried to infuse it throughout the sessions and will continue to.”
Late-breaking science
The LBS sessions kick off at 9:30 a.m. ET Saturday with AVATAR, a randomized trial of aortic valve replacement vs. watchful waiting in severe aortic stenosis proved asymptomatic through exercise testing.
“The findings of that trial, depending on what they are, could certainly impact clinical practice because it’s a very common scenario in which we have elderly patients with aortic valve stenosis that might be severe but they may not be symptomatic,” he said.
It’s followed by a randomized trial from the Cardiothoracic Surgical Trials Network, examining whether tricuspid repair at the time of mitral valve surgery leads to beneficial outcomes. “I think it’s a pretty important study,” Dr. Patel said, “because it’ll again affect how we think about our clinical practice.”
Rounding out the LBS.01 session is RAPID CABG, comparing early vs. delayed coronary bypass graft surgery (CABG) in patients with acute coronary syndromes on ticagrelor, and the pivotal U.S. VEST trial of an external support device already approved in Europe for saphenous vein grafts during CABG.
Saturday’s LBS.02 at 3:00 p.m. ET is devoted to hypertension and looks at how the COVID-19 pandemic affected blood pressure control. There’s also a study of remotely delivered hypertension and lipid management in 10,000 patients across the Partners Healthcare System and a cluster randomized trial of a village doctor–led blood pressure intervention in rural China.
Sunday’s LBS.03 at 8:00 a.m. ET is focused on atrial arrhythmias, starting with the CRAVE trial examining the effect of caffeine consumption on cardiac ectopy burden in 108 patients using an N-of-1 design and 2-day blocks on and off caffeine. “There’s an ability to identify a dose response that you get arrhythmias when you increase the amount of coffee you drink vs. not in an individual, so I think that will be likely discussed a lot and worth paying attention to,” Dr. Patel said.
The session also includes GIRAF, a comparison of cognitive outcomes with dabigatran (Pradaxa) vs. warfarin (Coumadin) in nonvalvular atrial fibrillation (AF); PALACS, a randomized trial examining whether left-sided pericardiotomy prevents AF after cardiac surgery; and AMAZE, which study sponsor AtriCure revealed missed its primary efficacy endpoint of freedom from AF with the LARIAT suture delivery device for left atrial appendage closure plus pulmonary vein isolation.
LBS.04 at 3:30 p.m. ET Sunday takes on digital health, with results from the nonrandomized Fitbit Heart Study on AF notifications from 450,000 participants wearing a single-lead ECG patch. “A lot of technologies claim that they can detect things, and we should ask that people go through the rigorous evaluation to see if they in fact do. So, in that respect, I think it›s an important step,” observed Dr. Patel.
Also on tap is I-STOP-AFib, another N-of-1 study using mobile apps and the AliveCor device to identify individual AF triggers; and REVeAL-HF, a 4,000-patient study examining whether electronic alerts that provide clinicians with prognostic information on their heart failure (HF) patients will reduce mortality and 30-day HF hospitalizations.
LBS.05 at 5:00 p.m. ET provides new information from EMPEROR-Preserved in HF with preserved ejection fraction and main results from EMPULSE, also using the sodium-glucose cotransporter 2 (SGLT2) inhibitor empagliflozin (Jardiance) in 530 patients hospitalized for acute HF.
The session also features CHIEF-HF, a randomized trial leveraging mobile technologies to test whether 12 weeks of another SGLT2 inhibitor, canagliflozin (Invokana), is superior to placebo for improving HF symptoms; and DREAM-HF, a comparison of transendocardial delivery of allogeneic mesenchymal precursor cells vs. a sham comparator in chronic HF as a result of left ventricular systolic dysfunction.
Monday’s LBS.06 at 8:00 a.m. ET details the safety and cholesterol-lowering efficacy of MK-0616, an investigational oral PCSK9 inhibitor. “It’s just a phase 2 [trial], but there’s interest in an oral PCSK9 inhibitor, given that the current ones are subcutaneous,” Dr. Patel said.
Results will also be presented from PREPARE-IT 2, which tested icosapent ethyl vs. placebo in outpatients with COVID-19. In the recently reported PREPARE-IT 1, a loading dose of icosapent ethyl failed to reduce the risk of hospitalization with SARS-CoV-2 infection among at-risk individuals.
LBS.07 at 11:00 a.m. Monday completes the late-breakers with new results from ASCEND, this time examining the effect of aspirin on dementia and cognitive impairment in patients with diabetes.
Next up is a look at the effectiveness of P2Y12 inhibitors in hospitalized patients with COVID-19 in the adaptive ACTIV-4a trial, followed by results of the pivotal phase 3 REVERSE-IT trial of bentracimab, a recombinant human monoclonal antibody antigen fragment designed to reverse the antiplatelet activity of ticagrelor in the event of major bleeding or when urgent surgery is needed.
Closing out the session is AXIOMATIC-TKR, a double-blind comparison of the safety and efficacy of the investigational oral factor XI anticoagulant JNJ-70033093 vs. subcutaneous enoxaparin (Lovenox) in elective total knee replacement.
For those searching for more AHA-related science online, the Resuscitation Science Symposium (ReSS) will run from this Friday through Sunday and the Quality of Care and Outcomes Research (QCOR) Scientific Sessions will take the stage next Monday, Nov. 15.
A version of this article first appeared on Medscape.com.
Virtual platforms democratized scientific meetings during the COVID-19 pandemic but, as any meeting-goer will tell you, it’s the questions from the floor and the back-and-forth of an expert panel that often reveal the importance of and/or problems with a presentation. It’s the scrutiny that makes the science resonate, especially in this postfactual era.
The all-virtual American Heart Association Scientific Sessions 2021 is looking to recreate the engagement of an in-person meeting by offering more live interactive events. They range from seven late-breaking science (LBS) sessions to Saturday’s fireside chat on the Pfizer and Moderna COVID-19 vaccines and Monday’s dive into the controversial new AHA/American College of Cardiology Chest Pain guidelines.
To help digest the latest science, attendees will be able to have their questions answered in real-time via Slido, meet with the trialists, and hear live commentary from key opinion leaders after the live events. A networking function will also allow attendees and exhibitors to chat or meet virtually.
“In this day and age, many people pretty quickly can get access to the science but it’s what I call the IC sort of phenomenon – the presentation of the information, the context of the information, putting it into how I’m going to use it in my practice, and then the critical appraisal – that’s what most people want at the Scientific Sessions,” program committee chair Manesh R. Patel, MD, of Duke University School of Medicine, said in an interview. “We’re all craving ways in which we can interact with one another to put things in context.”
Plans for a hybrid in-person meeting in Boston were scuttled in September because of the Delta variant surge, but the theme of the meeting remained: “One World. Together for Science.” Attendees will be able to access more than 500 live and on-demand sessions including 117 oral abstracts, 286 poster sessions, 59 moderated digital posters, and over a dozen sessions focused on strategies to promote health equity.
“Last year there was a Presidential Session and a statement on structural racism, so we wanted to take the next step and say, What are the ways in which people are starting to interact and do things to make a difference?” explained Dr. Patel. “So, this year, you’ll see different versions of that from the Main Event session, which has some case vignettes and a panel discussion, to other health equity sessions that describe not just COVID care, but blood pressure care, maternal-fetal medicine, and congenital kids. Wherever we can, we’ve tried to infuse it throughout the sessions and will continue to.”
Late-breaking science
The LBS sessions kick off at 9:30 a.m. ET Saturday with AVATAR, a randomized trial of aortic valve replacement vs. watchful waiting in severe aortic stenosis proved asymptomatic through exercise testing.
“The findings of that trial, depending on what they are, could certainly impact clinical practice because it’s a very common scenario in which we have elderly patients with aortic valve stenosis that might be severe but they may not be symptomatic,” he said.
It’s followed by a randomized trial from the Cardiothoracic Surgical Trials Network, examining whether tricuspid repair at the time of mitral valve surgery leads to beneficial outcomes. “I think it’s a pretty important study,” Dr. Patel said, “because it’ll again affect how we think about our clinical practice.”
Rounding out the LBS.01 session is RAPID CABG, comparing early vs. delayed coronary bypass graft surgery (CABG) in patients with acute coronary syndromes on ticagrelor, and the pivotal U.S. VEST trial of an external support device already approved in Europe for saphenous vein grafts during CABG.
Saturday’s LBS.02 at 3:00 p.m. ET is devoted to hypertension and looks at how the COVID-19 pandemic affected blood pressure control. There’s also a study of remotely delivered hypertension and lipid management in 10,000 patients across the Partners Healthcare System and a cluster randomized trial of a village doctor–led blood pressure intervention in rural China.
Sunday’s LBS.03 at 8:00 a.m. ET is focused on atrial arrhythmias, starting with the CRAVE trial examining the effect of caffeine consumption on cardiac ectopy burden in 108 patients using an N-of-1 design and 2-day blocks on and off caffeine. “There’s an ability to identify a dose response that you get arrhythmias when you increase the amount of coffee you drink vs. not in an individual, so I think that will be likely discussed a lot and worth paying attention to,” Dr. Patel said.
The session also includes GIRAF, a comparison of cognitive outcomes with dabigatran (Pradaxa) vs. warfarin (Coumadin) in nonvalvular atrial fibrillation (AF); PALACS, a randomized trial examining whether left-sided pericardiotomy prevents AF after cardiac surgery; and AMAZE, which study sponsor AtriCure revealed missed its primary efficacy endpoint of freedom from AF with the LARIAT suture delivery device for left atrial appendage closure plus pulmonary vein isolation.
LBS.04 at 3:30 p.m. ET Sunday takes on digital health, with results from the nonrandomized Fitbit Heart Study on AF notifications from 450,000 participants wearing a single-lead ECG patch. “A lot of technologies claim that they can detect things, and we should ask that people go through the rigorous evaluation to see if they in fact do. So, in that respect, I think it›s an important step,” observed Dr. Patel.
Also on tap is I-STOP-AFib, another N-of-1 study using mobile apps and the AliveCor device to identify individual AF triggers; and REVeAL-HF, a 4,000-patient study examining whether electronic alerts that provide clinicians with prognostic information on their heart failure (HF) patients will reduce mortality and 30-day HF hospitalizations.
LBS.05 at 5:00 p.m. ET provides new information from EMPEROR-Preserved in HF with preserved ejection fraction and main results from EMPULSE, also using the sodium-glucose cotransporter 2 (SGLT2) inhibitor empagliflozin (Jardiance) in 530 patients hospitalized for acute HF.
The session also features CHIEF-HF, a randomized trial leveraging mobile technologies to test whether 12 weeks of another SGLT2 inhibitor, canagliflozin (Invokana), is superior to placebo for improving HF symptoms; and DREAM-HF, a comparison of transendocardial delivery of allogeneic mesenchymal precursor cells vs. a sham comparator in chronic HF as a result of left ventricular systolic dysfunction.
Monday’s LBS.06 at 8:00 a.m. ET details the safety and cholesterol-lowering efficacy of MK-0616, an investigational oral PCSK9 inhibitor. “It’s just a phase 2 [trial], but there’s interest in an oral PCSK9 inhibitor, given that the current ones are subcutaneous,” Dr. Patel said.
Results will also be presented from PREPARE-IT 2, which tested icosapent ethyl vs. placebo in outpatients with COVID-19. In the recently reported PREPARE-IT 1, a loading dose of icosapent ethyl failed to reduce the risk of hospitalization with SARS-CoV-2 infection among at-risk individuals.
LBS.07 at 11:00 a.m. Monday completes the late-breakers with new results from ASCEND, this time examining the effect of aspirin on dementia and cognitive impairment in patients with diabetes.
Next up is a look at the effectiveness of P2Y12 inhibitors in hospitalized patients with COVID-19 in the adaptive ACTIV-4a trial, followed by results of the pivotal phase 3 REVERSE-IT trial of bentracimab, a recombinant human monoclonal antibody antigen fragment designed to reverse the antiplatelet activity of ticagrelor in the event of major bleeding or when urgent surgery is needed.
Closing out the session is AXIOMATIC-TKR, a double-blind comparison of the safety and efficacy of the investigational oral factor XI anticoagulant JNJ-70033093 vs. subcutaneous enoxaparin (Lovenox) in elective total knee replacement.
For those searching for more AHA-related science online, the Resuscitation Science Symposium (ReSS) will run from this Friday through Sunday and the Quality of Care and Outcomes Research (QCOR) Scientific Sessions will take the stage next Monday, Nov. 15.
A version of this article first appeared on Medscape.com.
FROM AHA 2021
Itchy belly
Examination revealed diffusely bordered periumbilical pink to violet scaly plaques consistent with nickel allergic contact dermatitis (Ni-ACD). The patient was wearing a belt with a buckle containing nickel, which had begun dispersing nickel. Her earlobes were also pierced and had similar scale and erythema around the metal earring studs
Ni-ACD is the most common, delayed-type hypersensitivity reaction worldwide. It affects 10% of people in the United States with a strong female predominance and a 4-fold increase in the last 30 years.1 The induction of nickel delayed-type hypersensitivity has been well-studied and includes nickel corrosion dissolving into a solution and exceeding an immunogenic threshold. Piercing practices, sweat, and friction facilitate this process.
Gold jewelry that’s less than 24 karat, “white gold,” and stainless steel all contain nickel and may cause allergy in sensitized individuals. It’s wise to assume that any shiny metal fashion accessory contains nickel, unless proven otherwise. Items can be tested for the presence of nickel with an inexpensive kit containing dimethylglyoxime.
Symptoms of Ni-ACD may range from mild erythema to thickened and weepy lichenified plaques. Distribution is often present at the site of exposure but may also be seen on the eyelids or hands from nickel transfer. A systematized reaction or id reaction is uncommon but can occur. Allergic contact dermatitis can be distinguished from psoriasis by a fading border rather than a sharp, well-demarcated border.
The patient in this case switched to a nonmetallic belt and earrings with plastic studs. She was prescribed topical triamcinolone cream 0.1% bid for 3 weeks, which led to clearance of her rash.
Text courtesy of Jonathan Karnes, MD, medical director, MDFMR Dermatology Services, Augusta, ME. Photos courtesy of Jonathan Karnes, MD (copyright retained).
1. Silverberg N, Pelletier JL, Jacob SE, et al. Nickel allergic contact dermatitis: identification, treatment, and prevention. Pediatrics. 2020;145:e20200628. doi: 10.1542/peds.2020-0628
Examination revealed diffusely bordered periumbilical pink to violet scaly plaques consistent with nickel allergic contact dermatitis (Ni-ACD). The patient was wearing a belt with a buckle containing nickel, which had begun dispersing nickel. Her earlobes were also pierced and had similar scale and erythema around the metal earring studs
Ni-ACD is the most common, delayed-type hypersensitivity reaction worldwide. It affects 10% of people in the United States with a strong female predominance and a 4-fold increase in the last 30 years.1 The induction of nickel delayed-type hypersensitivity has been well-studied and includes nickel corrosion dissolving into a solution and exceeding an immunogenic threshold. Piercing practices, sweat, and friction facilitate this process.
Gold jewelry that’s less than 24 karat, “white gold,” and stainless steel all contain nickel and may cause allergy in sensitized individuals. It’s wise to assume that any shiny metal fashion accessory contains nickel, unless proven otherwise. Items can be tested for the presence of nickel with an inexpensive kit containing dimethylglyoxime.
Symptoms of Ni-ACD may range from mild erythema to thickened and weepy lichenified plaques. Distribution is often present at the site of exposure but may also be seen on the eyelids or hands from nickel transfer. A systematized reaction or id reaction is uncommon but can occur. Allergic contact dermatitis can be distinguished from psoriasis by a fading border rather than a sharp, well-demarcated border.
The patient in this case switched to a nonmetallic belt and earrings with plastic studs. She was prescribed topical triamcinolone cream 0.1% bid for 3 weeks, which led to clearance of her rash.
Text courtesy of Jonathan Karnes, MD, medical director, MDFMR Dermatology Services, Augusta, ME. Photos courtesy of Jonathan Karnes, MD (copyright retained).
Examination revealed diffusely bordered periumbilical pink to violet scaly plaques consistent with nickel allergic contact dermatitis (Ni-ACD). The patient was wearing a belt with a buckle containing nickel, which had begun dispersing nickel. Her earlobes were also pierced and had similar scale and erythema around the metal earring studs
Ni-ACD is the most common, delayed-type hypersensitivity reaction worldwide. It affects 10% of people in the United States with a strong female predominance and a 4-fold increase in the last 30 years.1 The induction of nickel delayed-type hypersensitivity has been well-studied and includes nickel corrosion dissolving into a solution and exceeding an immunogenic threshold. Piercing practices, sweat, and friction facilitate this process.
Gold jewelry that’s less than 24 karat, “white gold,” and stainless steel all contain nickel and may cause allergy in sensitized individuals. It’s wise to assume that any shiny metal fashion accessory contains nickel, unless proven otherwise. Items can be tested for the presence of nickel with an inexpensive kit containing dimethylglyoxime.
Symptoms of Ni-ACD may range from mild erythema to thickened and weepy lichenified plaques. Distribution is often present at the site of exposure but may also be seen on the eyelids or hands from nickel transfer. A systematized reaction or id reaction is uncommon but can occur. Allergic contact dermatitis can be distinguished from psoriasis by a fading border rather than a sharp, well-demarcated border.
The patient in this case switched to a nonmetallic belt and earrings with plastic studs. She was prescribed topical triamcinolone cream 0.1% bid for 3 weeks, which led to clearance of her rash.
Text courtesy of Jonathan Karnes, MD, medical director, MDFMR Dermatology Services, Augusta, ME. Photos courtesy of Jonathan Karnes, MD (copyright retained).
1. Silverberg N, Pelletier JL, Jacob SE, et al. Nickel allergic contact dermatitis: identification, treatment, and prevention. Pediatrics. 2020;145:e20200628. doi: 10.1542/peds.2020-0628
1. Silverberg N, Pelletier JL, Jacob SE, et al. Nickel allergic contact dermatitis: identification, treatment, and prevention. Pediatrics. 2020;145:e20200628. doi: 10.1542/peds.2020-0628
Nonhealing incision and drainage site
Additional history from the family revealed that they were cleaning the wound with copious amounts of hydrogen peroxide twice a week—a practice that impedes wound healing and was ultimately the cause of this patient’s wound closure delay.
A nonhealing wound should be carefully evaluated to rule out malignancy, infection, or an inflammatory disorder such as pyoderma gangrenosum (PG). In this case, punch biopsies were performed to exclude PG and malignancy, particularly squamous cell carcinoma. Additionally, punch biopsies were performed for bacterial and fungal tissue culture. A complete blood count with differential was obtained to evaluate for signs of infection or hematologic malignancy. All work-ups and biopsies were consistent with a noninfected surgical wound.
Widely available over the counter in 3% to 5% solutions, hydrogen peroxide is used as a low-cost antiseptic for minor cuts and wounds. Data are mixed as to whether hydrogen peroxide improves or impedes wound healing when used outside of initial first aid or postoperatively.1 At higher concentrations, it uniformly causes skin necrosis. Owing to its debriding effect, it is FDA approved to treat seborrheic keratoses as an alternative to cryotherapy or electrodessication and curettage.
At the time of this work-up, and in the absence of other signs of infection, the patient and family were told to stop using hydrogen peroxide. Care instructions were changed to daily topical petroleum jelly and wound occlusion. Four weeks after wound care changes were made, the wound had re-epithelialized completely and reduced in size by two-thirds.
Text courtesy of Jonathan Karnes, MD, medical director, MDFMR Dermatology Services, Augusta, ME. Photos courtesy of Jonathan Karnes, MD (copyright retained).
1. Murphy EC, Friedman AJ. Hydrogen peroxide and cutaneous biology: translational applications, benefits, and risks. J Am Acad Dermatol. 2019;81:1379-1386. doi: 10.1016/j.jaad.2019.05.030
Additional history from the family revealed that they were cleaning the wound with copious amounts of hydrogen peroxide twice a week—a practice that impedes wound healing and was ultimately the cause of this patient’s wound closure delay.
A nonhealing wound should be carefully evaluated to rule out malignancy, infection, or an inflammatory disorder such as pyoderma gangrenosum (PG). In this case, punch biopsies were performed to exclude PG and malignancy, particularly squamous cell carcinoma. Additionally, punch biopsies were performed for bacterial and fungal tissue culture. A complete blood count with differential was obtained to evaluate for signs of infection or hematologic malignancy. All work-ups and biopsies were consistent with a noninfected surgical wound.
Widely available over the counter in 3% to 5% solutions, hydrogen peroxide is used as a low-cost antiseptic for minor cuts and wounds. Data are mixed as to whether hydrogen peroxide improves or impedes wound healing when used outside of initial first aid or postoperatively.1 At higher concentrations, it uniformly causes skin necrosis. Owing to its debriding effect, it is FDA approved to treat seborrheic keratoses as an alternative to cryotherapy or electrodessication and curettage.
At the time of this work-up, and in the absence of other signs of infection, the patient and family were told to stop using hydrogen peroxide. Care instructions were changed to daily topical petroleum jelly and wound occlusion. Four weeks after wound care changes were made, the wound had re-epithelialized completely and reduced in size by two-thirds.
Text courtesy of Jonathan Karnes, MD, medical director, MDFMR Dermatology Services, Augusta, ME. Photos courtesy of Jonathan Karnes, MD (copyright retained).
Additional history from the family revealed that they were cleaning the wound with copious amounts of hydrogen peroxide twice a week—a practice that impedes wound healing and was ultimately the cause of this patient’s wound closure delay.
A nonhealing wound should be carefully evaluated to rule out malignancy, infection, or an inflammatory disorder such as pyoderma gangrenosum (PG). In this case, punch biopsies were performed to exclude PG and malignancy, particularly squamous cell carcinoma. Additionally, punch biopsies were performed for bacterial and fungal tissue culture. A complete blood count with differential was obtained to evaluate for signs of infection or hematologic malignancy. All work-ups and biopsies were consistent with a noninfected surgical wound.
Widely available over the counter in 3% to 5% solutions, hydrogen peroxide is used as a low-cost antiseptic for minor cuts and wounds. Data are mixed as to whether hydrogen peroxide improves or impedes wound healing when used outside of initial first aid or postoperatively.1 At higher concentrations, it uniformly causes skin necrosis. Owing to its debriding effect, it is FDA approved to treat seborrheic keratoses as an alternative to cryotherapy or electrodessication and curettage.
At the time of this work-up, and in the absence of other signs of infection, the patient and family were told to stop using hydrogen peroxide. Care instructions were changed to daily topical petroleum jelly and wound occlusion. Four weeks after wound care changes were made, the wound had re-epithelialized completely and reduced in size by two-thirds.
Text courtesy of Jonathan Karnes, MD, medical director, MDFMR Dermatology Services, Augusta, ME. Photos courtesy of Jonathan Karnes, MD (copyright retained).
1. Murphy EC, Friedman AJ. Hydrogen peroxide and cutaneous biology: translational applications, benefits, and risks. J Am Acad Dermatol. 2019;81:1379-1386. doi: 10.1016/j.jaad.2019.05.030
1. Murphy EC, Friedman AJ. Hydrogen peroxide and cutaneous biology: translational applications, benefits, and risks. J Am Acad Dermatol. 2019;81:1379-1386. doi: 10.1016/j.jaad.2019.05.030
Pandemic and sleep: Increased stress, lack of exercise and insomnia
While working as a registered nurse on inpatient Stroke and Generalized Rehabilitation unit, she pursued for a degree in Adult and Gerontology Primary Care degree. She currently practices at UW Medicine/Harborview Medical Center for Sleep Medicine treating a variety of sleep disorders. She strives to provide quality and safe care to her patients.
1. According to the American Academy of Sleep Medicine, even in normal times, 30 to 35 % of the US population contends with acute, or short-term insomnia. As a board-certified nurse practitioner focusing on treating sleep disorders among older adults, can you discuss whether that percentage has increased during the coronavirus (COVID-19) pandemic, and if so, what would you say are the underlying reasons or causes?
As a sleep medicine nurse practitioner at UW (University of Washington) Medicine, I have seen quite a few patients with sleep disorders including acute and chronic insomnia. Since the start of the COVID-19 pandemic there has been a noticeable increase in poor-sleep complaints -- the data indicate a 37% increase in the rate of clinical insomnia since the pandemic started.
Stress can worsen insomnia, and the pandemic has negatively affected most if not everyone’s life. It has changed lifestyles through social distancing, mask mandates, and stay-at-home orders. Many have been forced to balance working from home with household duties; parents are supervising their children’s schooling. This disruption in the workday environment and workload can be hard to manage. The uncertainty of the pandemic has increased worries – health related and financially related. Ready access to media can also increase stress. Moreover, the lack of structure in a person’s day can cause many problems. Working from home, quarantining, living a more sedentary lifestyle, losing a job, losing socialization, including attending events, all can cause a disruption in a person’s daily routine and induce later bed- and wake-up times. This disruption to the body’s biological or circadian rhythm can reduce sleep quality and INCREASE phase-delay insomnia. Moreover, the pandemic has been especially hard on people’s mental health. One CDC study showed that 40% of adults are struggling with adverse mental health and substance-use issues due to COVID. Also, 13.3% of adults have responded to surveys saying they’ve started or increased their use of substances. As the pandemic continues, acute insomnia will likely turn into chronic insomnia.
2. How can increased stress and lack of exercise cause insomnia? What risk factors contribute to lack of sleep and impact our overall health?
The incidence of anxiety disorder and depressive disorder has increased significantly as compared to pre-pandemic rates. Psychological stress, especially at bedtime, increases psychophysiological arousal. The hypothalamic- pituitary- adrenal (HPA) axis responds to stress by releasing cortisol. HPA activation is associated with poorer sleep quality – it increases sleep latency, frequency of awakening, decreases in slow-wave sleep, and degrades overall sleep efficiency. The result of poor quality and fragmented sleep can further activate the HPA axis, causing a positive feedback loop.
A deterrent to poor sleep is physical activity. It greatly improves sleep by improving sleep efficiency, decreasing light sleep, increasing REM sleep, and regulating circadian rhythm. Lack of physical activity has been associated with increased sleep problems such as daytime sleepiness, an insufficient amount of sleep, snoring, sleep apnea symptoms, and restless sleep. And poor sleep further reduces physical activity which perpetuates the problem. The pandemic’s effect on physical activity is significant. It has caused people to stay home more often and therefore decreases in levels of exercise. and increased sedentary lifestyle. More than half of the adults in this country do not meet federal guidelines for aerobic physical activity.
Sleep deprivation can be dangerous, as sleepiness increases the likelihood of major occupational and road traffic accidents. Being awake for at least 18 hours is equivalent to having a blood alcohol content of 0.05% to 0.10% for 24 hours. Chronic sleep deprivation, defined as getting, on average, fewer than 7 hours per night negatively affects all systems of the body. Sleep deprivation therefore reduces quality of life and can reduce life expectancy.
Cardiovascular – Sleep deprivation can increase excessive heart age and reduce heart rate recovery after exercise. It is also linked to increases in heart rate, blood pressure, and death from cardiovascular issues.
Respiratory – Even one night of sleep deprivation can increase respiratory load. Studies have shown an association between sleep apnea and sleep deprivation. Sleep deprivation and respiratory disorders can perpetuate each other.
Neurologic – Sleep is crucial in brain development. Lack of sleep is associated with low grade neuroinflammation, memory and cognitive function decline, and acceleration of Alzheimer’s disease. Sleep deprivation can increase pain sensitivity, the risk of stroke, aggressive behavior, cognitive instability, hyperactivity, and socialization problems.
Endocrine – Sleep deprivation increases appetite stimulation causing excessive food intake and weight gain. It can also impair metabolism, which leads to obesity and insulin resistance.
Reproductive – Studies on sleep deprivation and the human reproduction system are limited. A study in male rats shows a relation between less sleep and overall lower reproductive health such as alteration of spermatic function, “decreased sexual behavior, lower testosterone level, and lower sperm viability level”. Studies also show renal dysfunction and high blood pressure in the offspring of sleep deprived rats in the last week of pregnancy.
3. Please discuss coronasomnia and its symptoms. Also, will you discuss your thoughts on the diagnosis and provide examples of the types of stressors associated with coronasomnia.
Coronasomnia is the term used to describe the increase in sleep problems associated with the COVID-19 pandemic. Coronasomnia is associated with increased sleep onset, maintenance insomnia, delayed sleep schedule, nocturnal awakening, sleep deprivation, and worsened pre-existing sleep issues. The worst insomnia and psychological symptoms are among those who are in the center of the pandemic, such as frontline workers and people living in areas more impacted by COVID-19.
During the pandemic, anxiety, depression, stress, and poor sleep have significantly increased. Anxiety and depression can be accompanied by intrusive thoughts which interfere with falling asleep. Patients with depression have a twofold risk of sleep disruption. Lack of daily routine may be associated with an increase in poor dental hygiene, such as lower rates of flossing and brushing.There’s also an increased rate in snacking (weight gain) and avoidance of visits to the dentists.
More time at home leads to more time spent on TV or social media. Increased screen time and media use at night, especially close to bedtime, are linked to poorer sleep. Blue light emitted by electronic devices can suppress the release of melatonin, making it more difficult to fall asleep. In addition, viewing or listening to content that is distressing or exciting right before bedtime negatively affects sleep quality. Following pandemic news for more than 3 hours a day has been found to be associated with increased levels of anxiety.
Health care providers are especially susceptible to coronasomnia. Those who work directly with COVID -19 patients are twice as likely to report disrupted sleep, anxiety, and depression. An increased work and patient load, the shortage of both fellow providers and supplies, all contribute to increased anxiety and disrupted sleep. Poor sleep, especially coupled with longer work hours and shift work, are associated with a worsened immune system and poor work performance.
4. In looking at the overall challenges pertaining to pandemic-induced sleep problems, what are your guideline recommendations to help ensure we sleep well during this outbreak?
Poor sleep can be detrimental to physical and mental health, and poor sleep hygiene practices can significantly impact sleep quality. Below are some general sleep-hygiene recommendations.
Caffeine – Caffeine consumed close to bedtime can disrupt sleep. Caffeine should be avoided 6 hours prior to bedtime. Everyone’s tolerance to caffeine is different so timing and caffeine dosage may need to be individually tailored.
Alcohol – Alcohol consumed close to bedtime can decrease sleep latency. However, it increases arousal during the second half of the night. It can also worsen snoring and sleep apnea. The effect can be alcohol level dependent.
Exercise – Regular exercise, as already discussed, is linked to better sleep quality. It is typically recommended to exercise earlier in the day; research has shown conflicting results on nighttime exercise. One study of patients with insomnia who exercised at night showed that aerobic exercise of moderate intensity improved polysomnography patient-reported sleep latency, and total sleep time.
Routine – An irregular sleep schedule is associated with poor sleep and daytime sleepiness. Following a consistent sleep schedule promotes stable circadian rhythm. A familiar relaxing routine should be established before bedtime.
Stress – To lower stress, patients should be advised to schedule brief meditation sessions so they can reflect on stressful situations. Patients also should limit the amount of exposure to pandemic news. Writing down and talking about stress, relaxation, and mindfulness techniques may reduce stress. However, stress and anxiety significantly differ case by case and interventions from health care providers may be needed.
Time in bed – Limit the amount of time in bed only for sleep and sex. Limit the use of electronics before bed and avoid use of electronics in bed. Turning off devices or silencing notifications can all help in reducing sleep disruption.
Cognitive behavioral therapy for insomnia (CBT-I) should be considered for patients with chronic insomnia. This therapy often includes sleep hygiene education, sleep restriction therapy, and relaxation training. Benefits of CBT-I treatment are long-term and reduce the need for additional pharmacologic therapies.
While many patients are experiencing insomnia these days, other underlying sleep disorders also should be considered. Patients should be evaluated to see if a sleep specialist is needed to diagnose and treat their sleep disorders.
Sleep Foundation. Sleep Guidelines and Help During the COVID-19 Pandemic. .Apr 7, 2021.
Morin CM, Carrier C. The acute effects of the COVID-19 pandemic on insomnia and psychological symptoms. Sleep Med. 2021: 77: 346–347. doi: 10.1016/j.sleep.2020.06.005
Pengpid S, Peltzer K. Sedentary Behaviour and 12 Sleep Problem Indicators among Middle-Aged and Elderly Adults in South Africa. Int J Environ Res Public Health. 2019 Apr; 16(8): 1422.
Czeisler M É, Lane RI, Petrosky E, et al. Mental Health, Substance Use, and Suicidal Ideation During the COVID-19 Pandemic — United States, June 24–30, 2020 | MMWR Weekly. Aug 14, 2020. 69(32);1049–1057.
van Dalfsen JH, Markus, CR. The influence of sleep on human hypothalamic–pituitary–adrenal (HPA)axis reactivity: A systematic review. Sleep Medicine Reviews. June 2018, 187-194. doi.org/10.1016/j.smrv.2017.10.002
Nicolaides NC, et al, eds. Axis and Sleep. Endotext - NCBI Bookshelf. South Dartmouth, MA. 2000- https://www.ncbi.nlm.nih.gov/books/NBK278943/
Issa FG and Sullivan CE. Alcohol, snoring and sleep apnea. J Neurol Neurosurg Psychiatry. 1982 Apr; 45: pp 353–359.
Liewa SC, Aung T. Sleep deprivation and its association with diseases- a review. Sleep Medicine. January 2021, pp 192-204.
Sleep Foundation. Coronasomnia: Definition, Symptoms, and Solutions | Sleep Foundation. Apr 14, 2021. https://www.sleepfoundation.org/covid-19-and-sleep/coronasomnia
American Association of Endodontists. Survey Reveals COVID-19 is a Major Factor in Americans’ Failing Dental Health | American Association of Endodontists (aae.org). Mar 4, 2021.
Altena E, Baglioni C, Espie CA, et al. Dealing with sleep problems during home confinement due to the COVID‐19 outbreak: Practical recommendations from a task force of the European CBT‐I Academy. J Sleep Res. April 4, 2020. doi.org/10.1111/jsr.13052 https://onlinelibrary.wiley.com/doi/10.1111/jsr.13052
CDC. Drowsy Driving- Sleep and Sleep Disorders. Mar 17, 2017. https://www.cdc.gov/sleep/about_sleep/drowsy_driving.html
Dolezal, BA, Neufeld, EV, Boland DM. Interrelationship between Sleep and Exercise: A Systematic Review. Adv Prev Med. 2017; 2017: 1364387. doi: 10.1155/2017/1364387
Irish LA, Kline, CE, Heather E. Gunn HE, et al. The Role of Sleep Hygiene in Promoting Public Health: A Review of Empirical Evidence.Sleep Med Rev. 2015 Aug; 22: 23–36.doi: 10.1016/j.smrv.2014.10.001
Edinger JD, Arnedt JT, Suzanne M. Bertisch SM, et al. Behavioral and psychological treatments for chronic insomnia disorder in adults: an American Academy of Sleep Medicine clinical practice guideline. J Clin Sleep Med. Feb. 1, 2021.
While working as a registered nurse on inpatient Stroke and Generalized Rehabilitation unit, she pursued for a degree in Adult and Gerontology Primary Care degree. She currently practices at UW Medicine/Harborview Medical Center for Sleep Medicine treating a variety of sleep disorders. She strives to provide quality and safe care to her patients.
1. According to the American Academy of Sleep Medicine, even in normal times, 30 to 35 % of the US population contends with acute, or short-term insomnia. As a board-certified nurse practitioner focusing on treating sleep disorders among older adults, can you discuss whether that percentage has increased during the coronavirus (COVID-19) pandemic, and if so, what would you say are the underlying reasons or causes?
As a sleep medicine nurse practitioner at UW (University of Washington) Medicine, I have seen quite a few patients with sleep disorders including acute and chronic insomnia. Since the start of the COVID-19 pandemic there has been a noticeable increase in poor-sleep complaints -- the data indicate a 37% increase in the rate of clinical insomnia since the pandemic started.
Stress can worsen insomnia, and the pandemic has negatively affected most if not everyone’s life. It has changed lifestyles through social distancing, mask mandates, and stay-at-home orders. Many have been forced to balance working from home with household duties; parents are supervising their children’s schooling. This disruption in the workday environment and workload can be hard to manage. The uncertainty of the pandemic has increased worries – health related and financially related. Ready access to media can also increase stress. Moreover, the lack of structure in a person’s day can cause many problems. Working from home, quarantining, living a more sedentary lifestyle, losing a job, losing socialization, including attending events, all can cause a disruption in a person’s daily routine and induce later bed- and wake-up times. This disruption to the body’s biological or circadian rhythm can reduce sleep quality and INCREASE phase-delay insomnia. Moreover, the pandemic has been especially hard on people’s mental health. One CDC study showed that 40% of adults are struggling with adverse mental health and substance-use issues due to COVID. Also, 13.3% of adults have responded to surveys saying they’ve started or increased their use of substances. As the pandemic continues, acute insomnia will likely turn into chronic insomnia.
2. How can increased stress and lack of exercise cause insomnia? What risk factors contribute to lack of sleep and impact our overall health?
The incidence of anxiety disorder and depressive disorder has increased significantly as compared to pre-pandemic rates. Psychological stress, especially at bedtime, increases psychophysiological arousal. The hypothalamic- pituitary- adrenal (HPA) axis responds to stress by releasing cortisol. HPA activation is associated with poorer sleep quality – it increases sleep latency, frequency of awakening, decreases in slow-wave sleep, and degrades overall sleep efficiency. The result of poor quality and fragmented sleep can further activate the HPA axis, causing a positive feedback loop.
A deterrent to poor sleep is physical activity. It greatly improves sleep by improving sleep efficiency, decreasing light sleep, increasing REM sleep, and regulating circadian rhythm. Lack of physical activity has been associated with increased sleep problems such as daytime sleepiness, an insufficient amount of sleep, snoring, sleep apnea symptoms, and restless sleep. And poor sleep further reduces physical activity which perpetuates the problem. The pandemic’s effect on physical activity is significant. It has caused people to stay home more often and therefore decreases in levels of exercise. and increased sedentary lifestyle. More than half of the adults in this country do not meet federal guidelines for aerobic physical activity.
Sleep deprivation can be dangerous, as sleepiness increases the likelihood of major occupational and road traffic accidents. Being awake for at least 18 hours is equivalent to having a blood alcohol content of 0.05% to 0.10% for 24 hours. Chronic sleep deprivation, defined as getting, on average, fewer than 7 hours per night negatively affects all systems of the body. Sleep deprivation therefore reduces quality of life and can reduce life expectancy.
Cardiovascular – Sleep deprivation can increase excessive heart age and reduce heart rate recovery after exercise. It is also linked to increases in heart rate, blood pressure, and death from cardiovascular issues.
Respiratory – Even one night of sleep deprivation can increase respiratory load. Studies have shown an association between sleep apnea and sleep deprivation. Sleep deprivation and respiratory disorders can perpetuate each other.
Neurologic – Sleep is crucial in brain development. Lack of sleep is associated with low grade neuroinflammation, memory and cognitive function decline, and acceleration of Alzheimer’s disease. Sleep deprivation can increase pain sensitivity, the risk of stroke, aggressive behavior, cognitive instability, hyperactivity, and socialization problems.
Endocrine – Sleep deprivation increases appetite stimulation causing excessive food intake and weight gain. It can also impair metabolism, which leads to obesity and insulin resistance.
Reproductive – Studies on sleep deprivation and the human reproduction system are limited. A study in male rats shows a relation between less sleep and overall lower reproductive health such as alteration of spermatic function, “decreased sexual behavior, lower testosterone level, and lower sperm viability level”. Studies also show renal dysfunction and high blood pressure in the offspring of sleep deprived rats in the last week of pregnancy.
3. Please discuss coronasomnia and its symptoms. Also, will you discuss your thoughts on the diagnosis and provide examples of the types of stressors associated with coronasomnia.
Coronasomnia is the term used to describe the increase in sleep problems associated with the COVID-19 pandemic. Coronasomnia is associated with increased sleep onset, maintenance insomnia, delayed sleep schedule, nocturnal awakening, sleep deprivation, and worsened pre-existing sleep issues. The worst insomnia and psychological symptoms are among those who are in the center of the pandemic, such as frontline workers and people living in areas more impacted by COVID-19.
During the pandemic, anxiety, depression, stress, and poor sleep have significantly increased. Anxiety and depression can be accompanied by intrusive thoughts which interfere with falling asleep. Patients with depression have a twofold risk of sleep disruption. Lack of daily routine may be associated with an increase in poor dental hygiene, such as lower rates of flossing and brushing.There’s also an increased rate in snacking (weight gain) and avoidance of visits to the dentists.
More time at home leads to more time spent on TV or social media. Increased screen time and media use at night, especially close to bedtime, are linked to poorer sleep. Blue light emitted by electronic devices can suppress the release of melatonin, making it more difficult to fall asleep. In addition, viewing or listening to content that is distressing or exciting right before bedtime negatively affects sleep quality. Following pandemic news for more than 3 hours a day has been found to be associated with increased levels of anxiety.
Health care providers are especially susceptible to coronasomnia. Those who work directly with COVID -19 patients are twice as likely to report disrupted sleep, anxiety, and depression. An increased work and patient load, the shortage of both fellow providers and supplies, all contribute to increased anxiety and disrupted sleep. Poor sleep, especially coupled with longer work hours and shift work, are associated with a worsened immune system and poor work performance.
4. In looking at the overall challenges pertaining to pandemic-induced sleep problems, what are your guideline recommendations to help ensure we sleep well during this outbreak?
Poor sleep can be detrimental to physical and mental health, and poor sleep hygiene practices can significantly impact sleep quality. Below are some general sleep-hygiene recommendations.
Caffeine – Caffeine consumed close to bedtime can disrupt sleep. Caffeine should be avoided 6 hours prior to bedtime. Everyone’s tolerance to caffeine is different so timing and caffeine dosage may need to be individually tailored.
Alcohol – Alcohol consumed close to bedtime can decrease sleep latency. However, it increases arousal during the second half of the night. It can also worsen snoring and sleep apnea. The effect can be alcohol level dependent.
Exercise – Regular exercise, as already discussed, is linked to better sleep quality. It is typically recommended to exercise earlier in the day; research has shown conflicting results on nighttime exercise. One study of patients with insomnia who exercised at night showed that aerobic exercise of moderate intensity improved polysomnography patient-reported sleep latency, and total sleep time.
Routine – An irregular sleep schedule is associated with poor sleep and daytime sleepiness. Following a consistent sleep schedule promotes stable circadian rhythm. A familiar relaxing routine should be established before bedtime.
Stress – To lower stress, patients should be advised to schedule brief meditation sessions so they can reflect on stressful situations. Patients also should limit the amount of exposure to pandemic news. Writing down and talking about stress, relaxation, and mindfulness techniques may reduce stress. However, stress and anxiety significantly differ case by case and interventions from health care providers may be needed.
Time in bed – Limit the amount of time in bed only for sleep and sex. Limit the use of electronics before bed and avoid use of electronics in bed. Turning off devices or silencing notifications can all help in reducing sleep disruption.
Cognitive behavioral therapy for insomnia (CBT-I) should be considered for patients with chronic insomnia. This therapy often includes sleep hygiene education, sleep restriction therapy, and relaxation training. Benefits of CBT-I treatment are long-term and reduce the need for additional pharmacologic therapies.
While many patients are experiencing insomnia these days, other underlying sleep disorders also should be considered. Patients should be evaluated to see if a sleep specialist is needed to diagnose and treat their sleep disorders.
While working as a registered nurse on inpatient Stroke and Generalized Rehabilitation unit, she pursued for a degree in Adult and Gerontology Primary Care degree. She currently practices at UW Medicine/Harborview Medical Center for Sleep Medicine treating a variety of sleep disorders. She strives to provide quality and safe care to her patients.
1. According to the American Academy of Sleep Medicine, even in normal times, 30 to 35 % of the US population contends with acute, or short-term insomnia. As a board-certified nurse practitioner focusing on treating sleep disorders among older adults, can you discuss whether that percentage has increased during the coronavirus (COVID-19) pandemic, and if so, what would you say are the underlying reasons or causes?
As a sleep medicine nurse practitioner at UW (University of Washington) Medicine, I have seen quite a few patients with sleep disorders including acute and chronic insomnia. Since the start of the COVID-19 pandemic there has been a noticeable increase in poor-sleep complaints -- the data indicate a 37% increase in the rate of clinical insomnia since the pandemic started.
Stress can worsen insomnia, and the pandemic has negatively affected most if not everyone’s life. It has changed lifestyles through social distancing, mask mandates, and stay-at-home orders. Many have been forced to balance working from home with household duties; parents are supervising their children’s schooling. This disruption in the workday environment and workload can be hard to manage. The uncertainty of the pandemic has increased worries – health related and financially related. Ready access to media can also increase stress. Moreover, the lack of structure in a person’s day can cause many problems. Working from home, quarantining, living a more sedentary lifestyle, losing a job, losing socialization, including attending events, all can cause a disruption in a person’s daily routine and induce later bed- and wake-up times. This disruption to the body’s biological or circadian rhythm can reduce sleep quality and INCREASE phase-delay insomnia. Moreover, the pandemic has been especially hard on people’s mental health. One CDC study showed that 40% of adults are struggling with adverse mental health and substance-use issues due to COVID. Also, 13.3% of adults have responded to surveys saying they’ve started or increased their use of substances. As the pandemic continues, acute insomnia will likely turn into chronic insomnia.
2. How can increased stress and lack of exercise cause insomnia? What risk factors contribute to lack of sleep and impact our overall health?
The incidence of anxiety disorder and depressive disorder has increased significantly as compared to pre-pandemic rates. Psychological stress, especially at bedtime, increases psychophysiological arousal. The hypothalamic- pituitary- adrenal (HPA) axis responds to stress by releasing cortisol. HPA activation is associated with poorer sleep quality – it increases sleep latency, frequency of awakening, decreases in slow-wave sleep, and degrades overall sleep efficiency. The result of poor quality and fragmented sleep can further activate the HPA axis, causing a positive feedback loop.
A deterrent to poor sleep is physical activity. It greatly improves sleep by improving sleep efficiency, decreasing light sleep, increasing REM sleep, and regulating circadian rhythm. Lack of physical activity has been associated with increased sleep problems such as daytime sleepiness, an insufficient amount of sleep, snoring, sleep apnea symptoms, and restless sleep. And poor sleep further reduces physical activity which perpetuates the problem. The pandemic’s effect on physical activity is significant. It has caused people to stay home more often and therefore decreases in levels of exercise. and increased sedentary lifestyle. More than half of the adults in this country do not meet federal guidelines for aerobic physical activity.
Sleep deprivation can be dangerous, as sleepiness increases the likelihood of major occupational and road traffic accidents. Being awake for at least 18 hours is equivalent to having a blood alcohol content of 0.05% to 0.10% for 24 hours. Chronic sleep deprivation, defined as getting, on average, fewer than 7 hours per night negatively affects all systems of the body. Sleep deprivation therefore reduces quality of life and can reduce life expectancy.
Cardiovascular – Sleep deprivation can increase excessive heart age and reduce heart rate recovery after exercise. It is also linked to increases in heart rate, blood pressure, and death from cardiovascular issues.
Respiratory – Even one night of sleep deprivation can increase respiratory load. Studies have shown an association between sleep apnea and sleep deprivation. Sleep deprivation and respiratory disorders can perpetuate each other.
Neurologic – Sleep is crucial in brain development. Lack of sleep is associated with low grade neuroinflammation, memory and cognitive function decline, and acceleration of Alzheimer’s disease. Sleep deprivation can increase pain sensitivity, the risk of stroke, aggressive behavior, cognitive instability, hyperactivity, and socialization problems.
Endocrine – Sleep deprivation increases appetite stimulation causing excessive food intake and weight gain. It can also impair metabolism, which leads to obesity and insulin resistance.
Reproductive – Studies on sleep deprivation and the human reproduction system are limited. A study in male rats shows a relation between less sleep and overall lower reproductive health such as alteration of spermatic function, “decreased sexual behavior, lower testosterone level, and lower sperm viability level”. Studies also show renal dysfunction and high blood pressure in the offspring of sleep deprived rats in the last week of pregnancy.
3. Please discuss coronasomnia and its symptoms. Also, will you discuss your thoughts on the diagnosis and provide examples of the types of stressors associated with coronasomnia.
Coronasomnia is the term used to describe the increase in sleep problems associated with the COVID-19 pandemic. Coronasomnia is associated with increased sleep onset, maintenance insomnia, delayed sleep schedule, nocturnal awakening, sleep deprivation, and worsened pre-existing sleep issues. The worst insomnia and psychological symptoms are among those who are in the center of the pandemic, such as frontline workers and people living in areas more impacted by COVID-19.
During the pandemic, anxiety, depression, stress, and poor sleep have significantly increased. Anxiety and depression can be accompanied by intrusive thoughts which interfere with falling asleep. Patients with depression have a twofold risk of sleep disruption. Lack of daily routine may be associated with an increase in poor dental hygiene, such as lower rates of flossing and brushing.There’s also an increased rate in snacking (weight gain) and avoidance of visits to the dentists.
More time at home leads to more time spent on TV or social media. Increased screen time and media use at night, especially close to bedtime, are linked to poorer sleep. Blue light emitted by electronic devices can suppress the release of melatonin, making it more difficult to fall asleep. In addition, viewing or listening to content that is distressing or exciting right before bedtime negatively affects sleep quality. Following pandemic news for more than 3 hours a day has been found to be associated with increased levels of anxiety.
Health care providers are especially susceptible to coronasomnia. Those who work directly with COVID -19 patients are twice as likely to report disrupted sleep, anxiety, and depression. An increased work and patient load, the shortage of both fellow providers and supplies, all contribute to increased anxiety and disrupted sleep. Poor sleep, especially coupled with longer work hours and shift work, are associated with a worsened immune system and poor work performance.
4. In looking at the overall challenges pertaining to pandemic-induced sleep problems, what are your guideline recommendations to help ensure we sleep well during this outbreak?
Poor sleep can be detrimental to physical and mental health, and poor sleep hygiene practices can significantly impact sleep quality. Below are some general sleep-hygiene recommendations.
Caffeine – Caffeine consumed close to bedtime can disrupt sleep. Caffeine should be avoided 6 hours prior to bedtime. Everyone’s tolerance to caffeine is different so timing and caffeine dosage may need to be individually tailored.
Alcohol – Alcohol consumed close to bedtime can decrease sleep latency. However, it increases arousal during the second half of the night. It can also worsen snoring and sleep apnea. The effect can be alcohol level dependent.
Exercise – Regular exercise, as already discussed, is linked to better sleep quality. It is typically recommended to exercise earlier in the day; research has shown conflicting results on nighttime exercise. One study of patients with insomnia who exercised at night showed that aerobic exercise of moderate intensity improved polysomnography patient-reported sleep latency, and total sleep time.
Routine – An irregular sleep schedule is associated with poor sleep and daytime sleepiness. Following a consistent sleep schedule promotes stable circadian rhythm. A familiar relaxing routine should be established before bedtime.
Stress – To lower stress, patients should be advised to schedule brief meditation sessions so they can reflect on stressful situations. Patients also should limit the amount of exposure to pandemic news. Writing down and talking about stress, relaxation, and mindfulness techniques may reduce stress. However, stress and anxiety significantly differ case by case and interventions from health care providers may be needed.
Time in bed – Limit the amount of time in bed only for sleep and sex. Limit the use of electronics before bed and avoid use of electronics in bed. Turning off devices or silencing notifications can all help in reducing sleep disruption.
Cognitive behavioral therapy for insomnia (CBT-I) should be considered for patients with chronic insomnia. This therapy often includes sleep hygiene education, sleep restriction therapy, and relaxation training. Benefits of CBT-I treatment are long-term and reduce the need for additional pharmacologic therapies.
While many patients are experiencing insomnia these days, other underlying sleep disorders also should be considered. Patients should be evaluated to see if a sleep specialist is needed to diagnose and treat their sleep disorders.
Sleep Foundation. Sleep Guidelines and Help During the COVID-19 Pandemic. .Apr 7, 2021.
Morin CM, Carrier C. The acute effects of the COVID-19 pandemic on insomnia and psychological symptoms. Sleep Med. 2021: 77: 346–347. doi: 10.1016/j.sleep.2020.06.005
Pengpid S, Peltzer K. Sedentary Behaviour and 12 Sleep Problem Indicators among Middle-Aged and Elderly Adults in South Africa. Int J Environ Res Public Health. 2019 Apr; 16(8): 1422.
Czeisler M É, Lane RI, Petrosky E, et al. Mental Health, Substance Use, and Suicidal Ideation During the COVID-19 Pandemic — United States, June 24–30, 2020 | MMWR Weekly. Aug 14, 2020. 69(32);1049–1057.
van Dalfsen JH, Markus, CR. The influence of sleep on human hypothalamic–pituitary–adrenal (HPA)axis reactivity: A systematic review. Sleep Medicine Reviews. June 2018, 187-194. doi.org/10.1016/j.smrv.2017.10.002
Nicolaides NC, et al, eds. Axis and Sleep. Endotext - NCBI Bookshelf. South Dartmouth, MA. 2000- https://www.ncbi.nlm.nih.gov/books/NBK278943/
Issa FG and Sullivan CE. Alcohol, snoring and sleep apnea. J Neurol Neurosurg Psychiatry. 1982 Apr; 45: pp 353–359.
Liewa SC, Aung T. Sleep deprivation and its association with diseases- a review. Sleep Medicine. January 2021, pp 192-204.
Sleep Foundation. Coronasomnia: Definition, Symptoms, and Solutions | Sleep Foundation. Apr 14, 2021. https://www.sleepfoundation.org/covid-19-and-sleep/coronasomnia
American Association of Endodontists. Survey Reveals COVID-19 is a Major Factor in Americans’ Failing Dental Health | American Association of Endodontists (aae.org). Mar 4, 2021.
Altena E, Baglioni C, Espie CA, et al. Dealing with sleep problems during home confinement due to the COVID‐19 outbreak: Practical recommendations from a task force of the European CBT‐I Academy. J Sleep Res. April 4, 2020. doi.org/10.1111/jsr.13052 https://onlinelibrary.wiley.com/doi/10.1111/jsr.13052
CDC. Drowsy Driving- Sleep and Sleep Disorders. Mar 17, 2017. https://www.cdc.gov/sleep/about_sleep/drowsy_driving.html
Dolezal, BA, Neufeld, EV, Boland DM. Interrelationship between Sleep and Exercise: A Systematic Review. Adv Prev Med. 2017; 2017: 1364387. doi: 10.1155/2017/1364387
Irish LA, Kline, CE, Heather E. Gunn HE, et al. The Role of Sleep Hygiene in Promoting Public Health: A Review of Empirical Evidence.Sleep Med Rev. 2015 Aug; 22: 23–36.doi: 10.1016/j.smrv.2014.10.001
Edinger JD, Arnedt JT, Suzanne M. Bertisch SM, et al. Behavioral and psychological treatments for chronic insomnia disorder in adults: an American Academy of Sleep Medicine clinical practice guideline. J Clin Sleep Med. Feb. 1, 2021.
Sleep Foundation. Sleep Guidelines and Help During the COVID-19 Pandemic. .Apr 7, 2021.
Morin CM, Carrier C. The acute effects of the COVID-19 pandemic on insomnia and psychological symptoms. Sleep Med. 2021: 77: 346–347. doi: 10.1016/j.sleep.2020.06.005
Pengpid S, Peltzer K. Sedentary Behaviour and 12 Sleep Problem Indicators among Middle-Aged and Elderly Adults in South Africa. Int J Environ Res Public Health. 2019 Apr; 16(8): 1422.
Czeisler M É, Lane RI, Petrosky E, et al. Mental Health, Substance Use, and Suicidal Ideation During the COVID-19 Pandemic — United States, June 24–30, 2020 | MMWR Weekly. Aug 14, 2020. 69(32);1049–1057.
van Dalfsen JH, Markus, CR. The influence of sleep on human hypothalamic–pituitary–adrenal (HPA)axis reactivity: A systematic review. Sleep Medicine Reviews. June 2018, 187-194. doi.org/10.1016/j.smrv.2017.10.002
Nicolaides NC, et al, eds. Axis and Sleep. Endotext - NCBI Bookshelf. South Dartmouth, MA. 2000- https://www.ncbi.nlm.nih.gov/books/NBK278943/
Issa FG and Sullivan CE. Alcohol, snoring and sleep apnea. J Neurol Neurosurg Psychiatry. 1982 Apr; 45: pp 353–359.
Liewa SC, Aung T. Sleep deprivation and its association with diseases- a review. Sleep Medicine. January 2021, pp 192-204.
Sleep Foundation. Coronasomnia: Definition, Symptoms, and Solutions | Sleep Foundation. Apr 14, 2021. https://www.sleepfoundation.org/covid-19-and-sleep/coronasomnia
American Association of Endodontists. Survey Reveals COVID-19 is a Major Factor in Americans’ Failing Dental Health | American Association of Endodontists (aae.org). Mar 4, 2021.
Altena E, Baglioni C, Espie CA, et al. Dealing with sleep problems during home confinement due to the COVID‐19 outbreak: Practical recommendations from a task force of the European CBT‐I Academy. J Sleep Res. April 4, 2020. doi.org/10.1111/jsr.13052 https://onlinelibrary.wiley.com/doi/10.1111/jsr.13052
CDC. Drowsy Driving- Sleep and Sleep Disorders. Mar 17, 2017. https://www.cdc.gov/sleep/about_sleep/drowsy_driving.html
Dolezal, BA, Neufeld, EV, Boland DM. Interrelationship between Sleep and Exercise: A Systematic Review. Adv Prev Med. 2017; 2017: 1364387. doi: 10.1155/2017/1364387
Irish LA, Kline, CE, Heather E. Gunn HE, et al. The Role of Sleep Hygiene in Promoting Public Health: A Review of Empirical Evidence.Sleep Med Rev. 2015 Aug; 22: 23–36.doi: 10.1016/j.smrv.2014.10.001
Edinger JD, Arnedt JT, Suzanne M. Bertisch SM, et al. Behavioral and psychological treatments for chronic insomnia disorder in adults: an American Academy of Sleep Medicine clinical practice guideline. J Clin Sleep Med. Feb. 1, 2021.
Treating endometriosis: maximizing all options for medical management, from hormones to new medical therapies
Stephanie J. Estes, MD is a board certified Obstetrician/Gynecologist and Professor of Reproductive Endocrinology and Infertility at the Penn State Hershey Medical center in Hershey, Pennsylvania. As a subspecialist, she has a focus on endometriosis and fibroid research and also advances the care of women through advanced reproductive surgery techniques and robotic surgery.
Q: At what point do you consider medical therapies in your approach to a patient with endometriosis?
Dr. Estes: I consider medical therapies for every patient that I see. There are 3 categories that I think about:
- Are they a candidate for medical therapy?
- Are they a candidate for surgical therapy?
- Lastly, are they a candidate for fertility treatment?
The difference between the plans is if the patient desires fertility. Next, I consider the advantages and disadvantages of medical therapy. The pros of medical therapy are avoiding the risks of surgery, with known and unknown complications or adhesions. And the cons are side effects of medical therapy. Also, medical therapy does not address treating hydrosalpinges, endometriomas, or other deep infiltrating nodules and, clearly, it also inhibits fertility treatment. So, my overall process is looking at the patient’s goal of symptom management and how best to limit their number of surgical procedures. My approach spans many options, and I look at all of those to make an appropriate decision for each patient.
Q: How do you determine what options would be best suited for the patient?
Dr. Estes: The first line of symptom treatment best suited for the patient is always NSAIDs, which are nonsteroidal anti-inflammatory drugs. These are an appropriate first start in managing the dysmenorrhea and pelvic pain that can be associated with endometriosis. If there are no contraindications, the next most common way to manage endometriosis symptoms is combined oral contraceptive pills, transdermal patches, or rings. A key principle, especially when selecting a pill, is to look at the type of estrogen and progestin you’re choosing. Some practitioners may see these pills as equals, but there are differences. I always select a 20-µm ethinyl estradiol pill for my endometriosis patients. Then, I select a progestin, such as norethindrone or levonorgestrel, which provide good suppressive treatment.
The preferred hormonal therapy for endometriosis symptoms not only should be easy for the patient to use but also accomplish management of the symptoms that they are coming in for. Hormonal therapies have a low side-effect profile, which allows the patient to feel well for a long time. We know that endometriosis is a chronic disease, so this is something that the patient is going to need to manage for a long time. I really like to help my patients because they have other things to do in life. They want to take care of their kids, or they’re in school, or have other goals. Patients want to feel well while doing all these activities of life, and so an individualized approach is important. Some of my patients love taking pills, and they are perfectly happy to do so. Other people would prefer a more long-acting treatment so that they do not have to deal with remembering to take a medication every day.
Q: Explain how you would apply the use of an intrauterine device (IUD) to manage endometriosis.
Dr. Estes: I use many IUDs with progestin because evidence has shown them to be effective in managing endometriosis symptoms, specifically by decreasing dysmenorrhea. I will usually insert them during a patient’s surgery in the operating room. If I identify endometriosis and can place the IUD at the same time of the surgery, this see-and-treat philosophy maximizes the efficiency of patient care—and the patient avoids the discomfort of an in-office insertion. During the patient’s post-operative check, I evaluate how they feel and how the IUD is working for them. I think many patients are candidates for progestin IUDs, especially those who cannot take an estrogen-containing compound.
Q: Where do newly available therapies for endometriosis fit into your overall management approach?
Dr. Estes: Norethindrone 5 mg is an effective treatment for endometriosis and it is US Food and Drug Administration (FDA)‒approved for that cause. And then, the other medications that Penn State Hershey was part of the clinical trials for include Gonadotropin-releasing hormone (GnRH) antagonists such as elagolix. I saw the improvement in symptoms not only in the trial but also in continued follow-up of patients. GnRH antagonists are a group of medications that have a very good side-effect profile. Patients typically do not have significant side effects, however, hot flashes can me common. Hot flashes that can be ameliorated with some add back hormone therapy. The other drugs in the pipeline are relugolix and linzagolix. Relugolix is FDA approved for prostate cancer treatment. Endometriosis trials are expensive, and they are long and hard to do because of the pain factor—people do not want to stop their other medications to do the trial; however, the use of these medications will continue to be studied, and I look further to continuing to fine tune treatment options
Q: Is cost to the patient a consideration during management counseling, and should it be?
Dr. Estes: Absolutely. It comes up in every conversation because endometriosis is a long-term disease process that needs to be managed throughout the life cycle of a woman; you cannot have something that is going to be so expensive that will have to be taken for years and years or is not going to be continued. Because cost is critical, I use Lupron Depot as well as letrozole, and goserelin implants are also approved for endometriosis treatment. I also occasionally use danazol, which is a very different mechanism of action in select patients, so multiple options are all present. We have streamlined our pre-approval process for the GnRH antagonists to make it fairly easy.
It used to be a little bit harder, but now, if a patient has found that other medications did not offer relief for her endometriosis, then GnRH antagonists are much easier to obtain.
Q: Is there anything else you’d like to add?
Dr. Estes: Our patient involvement in clinical trials is just so valuable for endometriosis disease research. So, anyone out there living with endometriosis who would like to help medical science—wherever you live, wherever you are—get involved because this can help not only you but also the next person who comes after you. We are currently participating in a study right now on quinagolide. It is a vaginal ring that is not hormonal.
Again, we want to keep all options open and see what works and does not work. Science is so fantastic, and it is one of those summary points to note that we always need more information in terms of endometriosis. We really are aspiring to develop and apply treatment options that are effective throughout the lifespan of those affected by endometriosis.
Stephanie J. Estes, MD is a board certified Obstetrician/Gynecologist and Professor of Reproductive Endocrinology and Infertility at the Penn State Hershey Medical center in Hershey, Pennsylvania. As a subspecialist, she has a focus on endometriosis and fibroid research and also advances the care of women through advanced reproductive surgery techniques and robotic surgery.
Q: At what point do you consider medical therapies in your approach to a patient with endometriosis?
Dr. Estes: I consider medical therapies for every patient that I see. There are 3 categories that I think about:
- Are they a candidate for medical therapy?
- Are they a candidate for surgical therapy?
- Lastly, are they a candidate for fertility treatment?
The difference between the plans is if the patient desires fertility. Next, I consider the advantages and disadvantages of medical therapy. The pros of medical therapy are avoiding the risks of surgery, with known and unknown complications or adhesions. And the cons are side effects of medical therapy. Also, medical therapy does not address treating hydrosalpinges, endometriomas, or other deep infiltrating nodules and, clearly, it also inhibits fertility treatment. So, my overall process is looking at the patient’s goal of symptom management and how best to limit their number of surgical procedures. My approach spans many options, and I look at all of those to make an appropriate decision for each patient.
Q: How do you determine what options would be best suited for the patient?
Dr. Estes: The first line of symptom treatment best suited for the patient is always NSAIDs, which are nonsteroidal anti-inflammatory drugs. These are an appropriate first start in managing the dysmenorrhea and pelvic pain that can be associated with endometriosis. If there are no contraindications, the next most common way to manage endometriosis symptoms is combined oral contraceptive pills, transdermal patches, or rings. A key principle, especially when selecting a pill, is to look at the type of estrogen and progestin you’re choosing. Some practitioners may see these pills as equals, but there are differences. I always select a 20-µm ethinyl estradiol pill for my endometriosis patients. Then, I select a progestin, such as norethindrone or levonorgestrel, which provide good suppressive treatment.
The preferred hormonal therapy for endometriosis symptoms not only should be easy for the patient to use but also accomplish management of the symptoms that they are coming in for. Hormonal therapies have a low side-effect profile, which allows the patient to feel well for a long time. We know that endometriosis is a chronic disease, so this is something that the patient is going to need to manage for a long time. I really like to help my patients because they have other things to do in life. They want to take care of their kids, or they’re in school, or have other goals. Patients want to feel well while doing all these activities of life, and so an individualized approach is important. Some of my patients love taking pills, and they are perfectly happy to do so. Other people would prefer a more long-acting treatment so that they do not have to deal with remembering to take a medication every day.
Q: Explain how you would apply the use of an intrauterine device (IUD) to manage endometriosis.
Dr. Estes: I use many IUDs with progestin because evidence has shown them to be effective in managing endometriosis symptoms, specifically by decreasing dysmenorrhea. I will usually insert them during a patient’s surgery in the operating room. If I identify endometriosis and can place the IUD at the same time of the surgery, this see-and-treat philosophy maximizes the efficiency of patient care—and the patient avoids the discomfort of an in-office insertion. During the patient’s post-operative check, I evaluate how they feel and how the IUD is working for them. I think many patients are candidates for progestin IUDs, especially those who cannot take an estrogen-containing compound.
Q: Where do newly available therapies for endometriosis fit into your overall management approach?
Dr. Estes: Norethindrone 5 mg is an effective treatment for endometriosis and it is US Food and Drug Administration (FDA)‒approved for that cause. And then, the other medications that Penn State Hershey was part of the clinical trials for include Gonadotropin-releasing hormone (GnRH) antagonists such as elagolix. I saw the improvement in symptoms not only in the trial but also in continued follow-up of patients. GnRH antagonists are a group of medications that have a very good side-effect profile. Patients typically do not have significant side effects, however, hot flashes can me common. Hot flashes that can be ameliorated with some add back hormone therapy. The other drugs in the pipeline are relugolix and linzagolix. Relugolix is FDA approved for prostate cancer treatment. Endometriosis trials are expensive, and they are long and hard to do because of the pain factor—people do not want to stop their other medications to do the trial; however, the use of these medications will continue to be studied, and I look further to continuing to fine tune treatment options
Q: Is cost to the patient a consideration during management counseling, and should it be?
Dr. Estes: Absolutely. It comes up in every conversation because endometriosis is a long-term disease process that needs to be managed throughout the life cycle of a woman; you cannot have something that is going to be so expensive that will have to be taken for years and years or is not going to be continued. Because cost is critical, I use Lupron Depot as well as letrozole, and goserelin implants are also approved for endometriosis treatment. I also occasionally use danazol, which is a very different mechanism of action in select patients, so multiple options are all present. We have streamlined our pre-approval process for the GnRH antagonists to make it fairly easy.
It used to be a little bit harder, but now, if a patient has found that other medications did not offer relief for her endometriosis, then GnRH antagonists are much easier to obtain.
Q: Is there anything else you’d like to add?
Dr. Estes: Our patient involvement in clinical trials is just so valuable for endometriosis disease research. So, anyone out there living with endometriosis who would like to help medical science—wherever you live, wherever you are—get involved because this can help not only you but also the next person who comes after you. We are currently participating in a study right now on quinagolide. It is a vaginal ring that is not hormonal.
Again, we want to keep all options open and see what works and does not work. Science is so fantastic, and it is one of those summary points to note that we always need more information in terms of endometriosis. We really are aspiring to develop and apply treatment options that are effective throughout the lifespan of those affected by endometriosis.
Stephanie J. Estes, MD is a board certified Obstetrician/Gynecologist and Professor of Reproductive Endocrinology and Infertility at the Penn State Hershey Medical center in Hershey, Pennsylvania. As a subspecialist, she has a focus on endometriosis and fibroid research and also advances the care of women through advanced reproductive surgery techniques and robotic surgery.
Q: At what point do you consider medical therapies in your approach to a patient with endometriosis?
Dr. Estes: I consider medical therapies for every patient that I see. There are 3 categories that I think about:
- Are they a candidate for medical therapy?
- Are they a candidate for surgical therapy?
- Lastly, are they a candidate for fertility treatment?
The difference between the plans is if the patient desires fertility. Next, I consider the advantages and disadvantages of medical therapy. The pros of medical therapy are avoiding the risks of surgery, with known and unknown complications or adhesions. And the cons are side effects of medical therapy. Also, medical therapy does not address treating hydrosalpinges, endometriomas, or other deep infiltrating nodules and, clearly, it also inhibits fertility treatment. So, my overall process is looking at the patient’s goal of symptom management and how best to limit their number of surgical procedures. My approach spans many options, and I look at all of those to make an appropriate decision for each patient.
Q: How do you determine what options would be best suited for the patient?
Dr. Estes: The first line of symptom treatment best suited for the patient is always NSAIDs, which are nonsteroidal anti-inflammatory drugs. These are an appropriate first start in managing the dysmenorrhea and pelvic pain that can be associated with endometriosis. If there are no contraindications, the next most common way to manage endometriosis symptoms is combined oral contraceptive pills, transdermal patches, or rings. A key principle, especially when selecting a pill, is to look at the type of estrogen and progestin you’re choosing. Some practitioners may see these pills as equals, but there are differences. I always select a 20-µm ethinyl estradiol pill for my endometriosis patients. Then, I select a progestin, such as norethindrone or levonorgestrel, which provide good suppressive treatment.
The preferred hormonal therapy for endometriosis symptoms not only should be easy for the patient to use but also accomplish management of the symptoms that they are coming in for. Hormonal therapies have a low side-effect profile, which allows the patient to feel well for a long time. We know that endometriosis is a chronic disease, so this is something that the patient is going to need to manage for a long time. I really like to help my patients because they have other things to do in life. They want to take care of their kids, or they’re in school, or have other goals. Patients want to feel well while doing all these activities of life, and so an individualized approach is important. Some of my patients love taking pills, and they are perfectly happy to do so. Other people would prefer a more long-acting treatment so that they do not have to deal with remembering to take a medication every day.
Q: Explain how you would apply the use of an intrauterine device (IUD) to manage endometriosis.
Dr. Estes: I use many IUDs with progestin because evidence has shown them to be effective in managing endometriosis symptoms, specifically by decreasing dysmenorrhea. I will usually insert them during a patient’s surgery in the operating room. If I identify endometriosis and can place the IUD at the same time of the surgery, this see-and-treat philosophy maximizes the efficiency of patient care—and the patient avoids the discomfort of an in-office insertion. During the patient’s post-operative check, I evaluate how they feel and how the IUD is working for them. I think many patients are candidates for progestin IUDs, especially those who cannot take an estrogen-containing compound.
Q: Where do newly available therapies for endometriosis fit into your overall management approach?
Dr. Estes: Norethindrone 5 mg is an effective treatment for endometriosis and it is US Food and Drug Administration (FDA)‒approved for that cause. And then, the other medications that Penn State Hershey was part of the clinical trials for include Gonadotropin-releasing hormone (GnRH) antagonists such as elagolix. I saw the improvement in symptoms not only in the trial but also in continued follow-up of patients. GnRH antagonists are a group of medications that have a very good side-effect profile. Patients typically do not have significant side effects, however, hot flashes can me common. Hot flashes that can be ameliorated with some add back hormone therapy. The other drugs in the pipeline are relugolix and linzagolix. Relugolix is FDA approved for prostate cancer treatment. Endometriosis trials are expensive, and they are long and hard to do because of the pain factor—people do not want to stop their other medications to do the trial; however, the use of these medications will continue to be studied, and I look further to continuing to fine tune treatment options
Q: Is cost to the patient a consideration during management counseling, and should it be?
Dr. Estes: Absolutely. It comes up in every conversation because endometriosis is a long-term disease process that needs to be managed throughout the life cycle of a woman; you cannot have something that is going to be so expensive that will have to be taken for years and years or is not going to be continued. Because cost is critical, I use Lupron Depot as well as letrozole, and goserelin implants are also approved for endometriosis treatment. I also occasionally use danazol, which is a very different mechanism of action in select patients, so multiple options are all present. We have streamlined our pre-approval process for the GnRH antagonists to make it fairly easy.
It used to be a little bit harder, but now, if a patient has found that other medications did not offer relief for her endometriosis, then GnRH antagonists are much easier to obtain.
Q: Is there anything else you’d like to add?
Dr. Estes: Our patient involvement in clinical trials is just so valuable for endometriosis disease research. So, anyone out there living with endometriosis who would like to help medical science—wherever you live, wherever you are—get involved because this can help not only you but also the next person who comes after you. We are currently participating in a study right now on quinagolide. It is a vaginal ring that is not hormonal.
Again, we want to keep all options open and see what works and does not work. Science is so fantastic, and it is one of those summary points to note that we always need more information in terms of endometriosis. We really are aspiring to develop and apply treatment options that are effective throughout the lifespan of those affected by endometriosis.
Enriched infant formula offers no academic benefit later: Study
Infants who are given nutrient- or supplement-enriched formula milk do not later have higher academic scores as adolescents than those fed with standard formula, a study published online in the BMJ suggests.
One goal of modifying infant formula has been to make long-term cognitive outcomes similar to those for breast-fed infants, the authors noted. Rates for breastfeeding beyond 6 weeks are low in many parts of the world and more than 60% of babies worldwide under the age of 6 months are given formula to replace or supplement breast milk, the paper states.
So far, research has been inconclusive on benefits, though enhancements continue to be added and claims have been made as to their benefits on cognition in advertising. Long-term trials are difficult as researchers move on and participants are lost to follow-up.
In a new study, however, researchers led by Maximiliane L. Verfürden, MsC, with the University College of London’s Great Ormond Street Institute of Child Health, linked data from seven dormant, randomized, controlled infant formula trials to participants’ performance later as adolescents in the United Kingdom on mandatory national school math and English exams at ages 11 and 16 and found no difference in scores.
They followed 1,763 adolescents who had been participants in the formula trials, which were conducted between 1993 and 2001, and were able to link 91.2% (1,607) to academic records.
They found “no benefit of the infant formula modifications on cognitive outcomes.”
Three types of formula studied
In this study, the researchers discuss three widely available types of modified infant formulas that have been promoted as benefiting cognitive development: formula enriched with nutrients; formula supplemented with long-chain polyunsaturated fatty acids (LCPUFAs); and follow-on formula fortified with iron.
In one supplement group the academic results were worse than for those given standard formula. At age 11, children who had been given the LCPUFA-enhanced formula scored lower in both English and math.
“Given the potential associations between the source of LCPUFAs and adverse cognitive outcomes, long-term follow-up of trials testing infant formulas from other sources of LCPUFAs is recommended,” the authors wrote.
Nutrients can harm, editorialist says
Charlotte Wright, BM BCH, MSc, a pediatrician and epidemiologist with the Glasgow Royal Hospital for Children in Glasgow, who was not part of the study, coauthored an editorial that accompanied the article in the BMJ.
Dr. Wright and nutritionist Ada L. Gargia, PhD, at the University of Glasgow, wrote that nutrients in some formula enhancements can harm and that infant milk trials often have been poorly conducted.
The editorialists point to a large systematic review of formula milk trials published this year in the BMJ by Helfer et al. that found that most were funded by industry.
“Helfer and colleagues’ review found that 80% of studies were at high risk of bias, mainly because of selective reporting, with 92% of abstracts mentioning positive findings, despite only 42% of trials finding statistically significant differences in a stated primary outcome,” they wrote.
Dr. Wright, who runs a specialist feeding clinic for children, said in an interview that the study is valuable in that it has follow-up “to an age when adult cognition can be robustly assessed.”
She noted that the authors say additives that have been shown to be harmful are still routinely added.
“There is now evidence that adding LCPUFAs results in lower cognition and that giving extra iron to healthy children increases their risk of infection and may even slow their growth,” she said.
But advertisements to the contrary are quickly found in an Internet search, she said, even if no specific claims are made for them.
She gave an example of an advertisement for a commonly used enhanced formula, which reads: “Our formulation contains our highest levels of DHA (Omega 3 LCPs) and is enriched with iron to support normal cognitive development.”
The formula studies were done more than 20 years ago, but Dr. Wright said that does not downplay their relevance.
The basic formulation of the formulas hasn’t changed much, she said, and the additives are still present.
This work was supported by the Economic and Social Research Council UCL, Bloomsbury and East London Doctoral Training Partnership and a Great Ormond Street Hospital Charity Research grant. Full disclosures for all authors are available with the full text of the paper. Dr. Wright and Dr. Garcia declared no relevant financial relationships.
Infants who are given nutrient- or supplement-enriched formula milk do not later have higher academic scores as adolescents than those fed with standard formula, a study published online in the BMJ suggests.
One goal of modifying infant formula has been to make long-term cognitive outcomes similar to those for breast-fed infants, the authors noted. Rates for breastfeeding beyond 6 weeks are low in many parts of the world and more than 60% of babies worldwide under the age of 6 months are given formula to replace or supplement breast milk, the paper states.
So far, research has been inconclusive on benefits, though enhancements continue to be added and claims have been made as to their benefits on cognition in advertising. Long-term trials are difficult as researchers move on and participants are lost to follow-up.
In a new study, however, researchers led by Maximiliane L. Verfürden, MsC, with the University College of London’s Great Ormond Street Institute of Child Health, linked data from seven dormant, randomized, controlled infant formula trials to participants’ performance later as adolescents in the United Kingdom on mandatory national school math and English exams at ages 11 and 16 and found no difference in scores.
They followed 1,763 adolescents who had been participants in the formula trials, which were conducted between 1993 and 2001, and were able to link 91.2% (1,607) to academic records.
They found “no benefit of the infant formula modifications on cognitive outcomes.”
Three types of formula studied
In this study, the researchers discuss three widely available types of modified infant formulas that have been promoted as benefiting cognitive development: formula enriched with nutrients; formula supplemented with long-chain polyunsaturated fatty acids (LCPUFAs); and follow-on formula fortified with iron.
In one supplement group the academic results were worse than for those given standard formula. At age 11, children who had been given the LCPUFA-enhanced formula scored lower in both English and math.
“Given the potential associations between the source of LCPUFAs and adverse cognitive outcomes, long-term follow-up of trials testing infant formulas from other sources of LCPUFAs is recommended,” the authors wrote.
Nutrients can harm, editorialist says
Charlotte Wright, BM BCH, MSc, a pediatrician and epidemiologist with the Glasgow Royal Hospital for Children in Glasgow, who was not part of the study, coauthored an editorial that accompanied the article in the BMJ.
Dr. Wright and nutritionist Ada L. Gargia, PhD, at the University of Glasgow, wrote that nutrients in some formula enhancements can harm and that infant milk trials often have been poorly conducted.
The editorialists point to a large systematic review of formula milk trials published this year in the BMJ by Helfer et al. that found that most were funded by industry.
“Helfer and colleagues’ review found that 80% of studies were at high risk of bias, mainly because of selective reporting, with 92% of abstracts mentioning positive findings, despite only 42% of trials finding statistically significant differences in a stated primary outcome,” they wrote.
Dr. Wright, who runs a specialist feeding clinic for children, said in an interview that the study is valuable in that it has follow-up “to an age when adult cognition can be robustly assessed.”
She noted that the authors say additives that have been shown to be harmful are still routinely added.
“There is now evidence that adding LCPUFAs results in lower cognition and that giving extra iron to healthy children increases their risk of infection and may even slow their growth,” she said.
But advertisements to the contrary are quickly found in an Internet search, she said, even if no specific claims are made for them.
She gave an example of an advertisement for a commonly used enhanced formula, which reads: “Our formulation contains our highest levels of DHA (Omega 3 LCPs) and is enriched with iron to support normal cognitive development.”
The formula studies were done more than 20 years ago, but Dr. Wright said that does not downplay their relevance.
The basic formulation of the formulas hasn’t changed much, she said, and the additives are still present.
This work was supported by the Economic and Social Research Council UCL, Bloomsbury and East London Doctoral Training Partnership and a Great Ormond Street Hospital Charity Research grant. Full disclosures for all authors are available with the full text of the paper. Dr. Wright and Dr. Garcia declared no relevant financial relationships.
Infants who are given nutrient- or supplement-enriched formula milk do not later have higher academic scores as adolescents than those fed with standard formula, a study published online in the BMJ suggests.
One goal of modifying infant formula has been to make long-term cognitive outcomes similar to those for breast-fed infants, the authors noted. Rates for breastfeeding beyond 6 weeks are low in many parts of the world and more than 60% of babies worldwide under the age of 6 months are given formula to replace or supplement breast milk, the paper states.
So far, research has been inconclusive on benefits, though enhancements continue to be added and claims have been made as to their benefits on cognition in advertising. Long-term trials are difficult as researchers move on and participants are lost to follow-up.
In a new study, however, researchers led by Maximiliane L. Verfürden, MsC, with the University College of London’s Great Ormond Street Institute of Child Health, linked data from seven dormant, randomized, controlled infant formula trials to participants’ performance later as adolescents in the United Kingdom on mandatory national school math and English exams at ages 11 and 16 and found no difference in scores.
They followed 1,763 adolescents who had been participants in the formula trials, which were conducted between 1993 and 2001, and were able to link 91.2% (1,607) to academic records.
They found “no benefit of the infant formula modifications on cognitive outcomes.”
Three types of formula studied
In this study, the researchers discuss three widely available types of modified infant formulas that have been promoted as benefiting cognitive development: formula enriched with nutrients; formula supplemented with long-chain polyunsaturated fatty acids (LCPUFAs); and follow-on formula fortified with iron.
In one supplement group the academic results were worse than for those given standard formula. At age 11, children who had been given the LCPUFA-enhanced formula scored lower in both English and math.
“Given the potential associations between the source of LCPUFAs and adverse cognitive outcomes, long-term follow-up of trials testing infant formulas from other sources of LCPUFAs is recommended,” the authors wrote.
Nutrients can harm, editorialist says
Charlotte Wright, BM BCH, MSc, a pediatrician and epidemiologist with the Glasgow Royal Hospital for Children in Glasgow, who was not part of the study, coauthored an editorial that accompanied the article in the BMJ.
Dr. Wright and nutritionist Ada L. Gargia, PhD, at the University of Glasgow, wrote that nutrients in some formula enhancements can harm and that infant milk trials often have been poorly conducted.
The editorialists point to a large systematic review of formula milk trials published this year in the BMJ by Helfer et al. that found that most were funded by industry.
“Helfer and colleagues’ review found that 80% of studies were at high risk of bias, mainly because of selective reporting, with 92% of abstracts mentioning positive findings, despite only 42% of trials finding statistically significant differences in a stated primary outcome,” they wrote.
Dr. Wright, who runs a specialist feeding clinic for children, said in an interview that the study is valuable in that it has follow-up “to an age when adult cognition can be robustly assessed.”
She noted that the authors say additives that have been shown to be harmful are still routinely added.
“There is now evidence that adding LCPUFAs results in lower cognition and that giving extra iron to healthy children increases their risk of infection and may even slow their growth,” she said.
But advertisements to the contrary are quickly found in an Internet search, she said, even if no specific claims are made for them.
She gave an example of an advertisement for a commonly used enhanced formula, which reads: “Our formulation contains our highest levels of DHA (Omega 3 LCPs) and is enriched with iron to support normal cognitive development.”
The formula studies were done more than 20 years ago, but Dr. Wright said that does not downplay their relevance.
The basic formulation of the formulas hasn’t changed much, she said, and the additives are still present.
This work was supported by the Economic and Social Research Council UCL, Bloomsbury and East London Doctoral Training Partnership and a Great Ormond Street Hospital Charity Research grant. Full disclosures for all authors are available with the full text of the paper. Dr. Wright and Dr. Garcia declared no relevant financial relationships.
FROM THE BMJ